FDA 510(k) Device Information
What Is FDA 510(k) Clearance?
FDA 510(k) clearance is a premarket authorization that lets a medical device be legally marketed in the United States after the manufacturer demonstrates it is “substantially equivalent” to a device already on the market (a predicate). Named after Section 510(k) of the Federal Food, Drug, and Cosmetic Act, it is the pathway most moderate-risk (Class II) diagnostic and therapeutic devices follow. HealthWright Technologies distributes medical devices built on FDA-cleared components. Clearance applies at the component level rather than to a bundled system, and some items we supply are Class I exempt and carry no clearance of their own. We provide the clearance documentation we hold on request.
In practical terms, FDA 510(k) clearance tells a physician that the FDA has reviewed the device, compared it to a legally marketed predicate, and agreed it is at least as safe and effective for its intended use. You can verify the clearance status of any device through the FDA 510(k) Premarket Notification Database by searching the device name, manufacturer, or K-number.
You will often see this pathway written as 510k, without the parentheses, in device catalogs, purchasing paperwork, and search results. 510k and 510(k) refer to the same thing. The parenthetical form matches the wording of the statute, while the shorter 510k spelling is simply how the term gets typed in everyday practice. Either way, the underlying record is the same premarket notification held in the FDA database, and a device described as 510k cleared carries the same regulatory status as one described as 510(k) cleared.
FDA Clearance vs. FDA Approval: What’s the Difference?
“FDA-cleared” and “FDA-approved” are not interchangeable, and the distinction matters for accurate clinical and marketing language. Devices that pass the 510(k) pathway are cleared; only high-risk (Class III) devices that go through the more rigorous Premarket Approval (PMA) process are approved. The table below summarizes the three FDA marketing pathways for medical devices.
| Pathway | Device risk level | Standard of review | FDA outcome |
|---|---|---|---|
| 510(k) Premarket Notification | Low to moderate (most Class II) | Substantial equivalence to a legally marketed predicate device | Cleared |
| PMA (Premarket Approval) | High (Class III, life-sustaining/supporting) | Independent clinical evidence of safety and effectiveness | Approved |
| De Novo | Low to moderate, no predicate exists | Risk-based review that creates a new device classification | Granted (marketing authorization) |
Note that individual pharmaceutical products are a separate category: the medications a practice dispenses are FDA-approved drugs, while the diagnostic and therapeutic devices in our catalog are FDA-cleared. Using the correct term keeps your patient-facing and payer-facing documentation accurate.
How to Verify a Device’s FDA 510(k) Clearance
Any healthcare provider can independently confirm a device’s regulatory status in a few minutes:
- Open the FDA 510(k) Premarket Notification Database maintained by the FDA’s Center for Devices and Radiological Health.
- Search by the device name, the manufacturer/applicant, or the 510(k) number (the “K” number, e.g., K173696).
- Review the clearance record, including the decision date, product code, and the predicate device cited.
- Request the available 510(k) clearance letter and product labeling from your distributor for your compliance file. HealthWright Technologies provides the regulatory documentation we hold on request at contact@healthwrighttechnologies.com.
FDA Device Classes and the 510(k) Pathway
The FDA sorts medical devices into three regulatory classes based on the level of risk they pose to patients, and the class determines which pathway a device must follow. Class I devices are low-risk (such as exam gloves or bandages) and most are exempt from premarket review. Class II devices are moderate-risk and typically require FDA 510(k) clearance. This is where the majority of diagnostic and therapeutic office devices, including the systems HealthWright Technologies distributes, are classified.
Class III devices are the highest-risk, life-sustaining or life-supporting devices and generally require the more demanding Premarket Approval (PMA) pathway. Understanding your device’s class helps you interpret its regulatory record and set accurate expectations with patients, staff, and payers about how the device was authorized for the U.S. market.
FDA-Cleared Product Lines Distributed by HealthWright Technologies
HealthWright Technologies distributes device systems built on FDA-cleared components, along with supporting accessories that carry their own FDA classifications. Explore our full product catalog and practice solutions, or review the individual product lines below.
CMAT Advantage™ System
The CMAT Advantage System is HealthWright Technologies’ point-of-care diagnostic system, built on FDA-cleared component devices. It is a non-invasive diagnostic device used in the medical office to perform established measurements: ankle-brachial index (ABI), sudomotor function, and heart-rate variability (HRV). The device uses FDA-cleared components built by LD Technology, LLC (Miami, FL); the TBL-ABI module holds 510(k) clearance (K173696) for non-invasive vascular assessment. It is a diagnostic device, not a practice-management, billing, or software platform. Learn more about what the CMAT Advantage system does.
TM-Flow System
The TM-Flow system is a non-invasive diagnostic testing platform built on FDA-cleared component devices, providing measurements including autonomic nervous system testing, ankle-brachial index (ABI) measurements, and sudomotor function testing. These measurements support the evaluation of peripheral neuropathy, peripheral arterial disease, and cardiac autonomic dysfunction. The device is intended for use by healthcare professionals as part of a comprehensive patient evaluation.
Hako-Med Horizontal Therapy Systems
The Hako-Med Horizontal Therapy system is labeled by its manufacturer as an FDA Class II electrotherapy device used for non-narcotic pain management and rehabilitation. It delivers proprietary bioelectrical signals for the treatment of chronic and acute pain conditions and is indicated for use by licensed healthcare professionals in clinical settings. Please refer to the manufacturer’s product labeling for complete indications, contraindications, and 510(k) clearance details.
Mini C-Arm Imaging Systems
Our mini C-arm imaging systems line covers portable extremity fluoroscopy units we source for licensed practices. The OrthoScan Mobile DI holds FDA 510(k) clearance K113708, and the Hologic Fluoroscan InSight family holds clearances K051025 and K120388 (FDA records list these as Fluoroscan InSight and InSight FD). The GE OEC Series 6600 we also supply holds K951765 as a mobile C-arm fluoroscopic X-ray system. The MediCapture USB 170 image recorder is a supporting accessory in a different FDA category: digital image storage devices of its type are Class I and exempt from 510(k) premarket notification. For pre-owned units, we provide the manufacturer documentation we hold for that specific unit.
SCRIPT Physician Dispensing Solutions
The SCRIPT system provides physician point-of-care dispensing, enabling providers to dispense FDA-approved medications directly to patients at the time of their visit. All medications dispensed through the SCRIPT system are FDA-approved pharmaceutical products, and dispensing is subject to applicable state pharmacy regulations and licensing requirements. (Because SCRIPT dispenses drugs rather than devices, the correct term here is FDA-approved, not 510(k)-cleared.)
Why FDA Clearance Matters for Your Practice
When you choose FDA-cleared medical devices from HealthWright Technologies, each product has completed FDA premarket review before distribution. FDA 510(k) clearance means FDA found the device substantially equivalent to a legally marketed predicate; it is not an assurance of safety or of labeling accuracy. It is important to understand that clearance is a regulatory determination of substantial equivalence, not an FDA endorsement or a guarantee of any specific clinical result, so devices should always be used within their cleared indications for use.
For healthcare providers, using FDA-cleared devices supports documentation quality and compliance with facility accreditation requirements. Reimbursement is a separate matter: testing is addressed under Medicare Local Coverage Determinations when medical necessity is documented, so confirm coverage with your Medicare Administrative Contractor’s LCD. As of 2026, the diagnostic device systems in our catalog are built on FDA 510(k)-cleared components; accessories and therapeutic devices carry their own FDA classifications, and we keep the corresponding regulatory records available for the practices we serve.
Sourcing FDA-cleared device systems reflects a commitment to patient safety and clinical excellence that independent practices can build on. Each cleared system was found by FDA to be substantially equivalent to a legally marketed predicate, giving your patients and your compliance team confidence in the technology you deploy. Review our product safety information for additional labeling and safety resources.
Requesting Regulatory Documentation
Healthcare providers may request copies of available 510(k) clearance letters, product labeling, and manufacturer documentation for the devices we distribute. Our team can provide the regulatory documentation we hold, including 510(k) summary letters and device classification information. For resold or pre-owned OEM equipment, such as mini C-arm systems, we provide the manufacturer documentation we hold for that specific unit. To request documentation, contact us at contact@healthwrighttechnologies.com or visit our contact page. To learn more about the company behind the catalog, see our About Us page.
Frequently Asked Questions About FDA 510(k) Clearance
Is 510k the same as 510(k)?
Yes. 510k and 510(k) are two spellings of the same FDA premarket notification pathway. The form with parentheses follows Section 510(k) of the Federal Food, Drug, and Cosmetic Act, and the shorter 510k spelling is the version most often typed into search boxes, product catalogs, and purchase orders. A device listed as 510k cleared and one listed as 510(k) cleared hold identical regulatory status, and both appear under the same record in the FDA 510(k) Premarket Notification Database.
Is FDA 510(k) clearance the same as FDA approval?
No. FDA 510(k) clearance is granted when a device is shown to be substantially equivalent to a legally marketed predicate device, and it applies to most moderate-risk (Class II) devices. FDA approval refers to the separate, more rigorous Premarket Approval (PMA) pathway required for high-risk (Class III) devices that must demonstrate safety and effectiveness through independent clinical evidence. The medical devices HealthWright Technologies distributes are FDA-cleared, not FDA-approved.
How can I verify a device’s FDA 510(k) clearance?
Search the FDA 510(k) Premarket Notification Database by device name, manufacturer, or 510(k) “K” number. The record shows the clearance date, product code, and predicate device. You can also request the available 510(k) clearance letter and product labeling we hold directly from HealthWright Technologies for your compliance file.
Are HealthWright Technologies’ devices FDA-cleared?
Yes. The device systems HealthWright Technologies distributes are built on FDA 510(k)-cleared devices: the TM-Flow and CMAT Advantage systems use FDA-cleared components (the CMAT Advantage’s TBL-ABI module holds clearance K173696), and the mini C-arm systems we supply hold their own clearances. The Hako-Med Horizontal Therapy system is labeled by its manufacturer as an FDA Class II device; refer to the manufacturer’s labeling for its clearance details.
What is the 510(k) number for the CMAT Advantage system?
The CMAT Advantage system is built on FDA-cleared components manufactured by LD Technology, LLC. Its TBL-ABI module holds FDA 510(k) clearance K173696 for non-invasive vascular assessment. HealthWright Technologies can provide the corresponding clearance documentation on request.
Does FDA 510(k) clearance affect Medicare reimbursement?
FDA 510(k) clearance is a regulatory determination and is separate from coverage decisions, though using FDA-cleared devices helps satisfy facility accreditation requirements. Reimbursement is addressed under Medicare Local Coverage Determinations when medical necessity is documented, and it depends on the specific test and the documentation in the record. Confirm coverage with your Medicare Administrative Contractor’s LCD, and contact us if you need the regulatory records that support your billing and accreditation files.
Disclaimer: The information on this page is provided for general informational purposes and does not constitute medical or legal advice. Product-specific regulatory information, indications for use, contraindications, warnings, and precautions are available in each product’s Instructions for Use and labeling. Healthcare providers should always refer to complete product labeling before using any medical device. Last updated: August 2026.