How to Verify a Medical Device's FDA Clearance Before You Sign

Why "FDA registered" is not "FDA cleared"

Product pages and sales decks lean on phrases like "FDA registered" and "FDA listed." They sound like an endorsement. They are not.

Registration and listing is an administrative requirement: manufacturers register their facilities with FDA and list the devices they make. FDA states plainly that an entry in its registration and listing database does not denote approval, clearance or authorization of a facility or its devices, and that suggesting otherwise is misleading. FDA doesn't issue registration certificates either, so any "FDA certificate of registration" you are shown was produced by someone other than FDA.

For a buyer the practical rule is simple. When a vendor says a device is FDA cleared or approved, ask for the submission number and look it up yourself.

The three premarket pathways, and the words that go with them

Medical devices are classified by risk: Class I is the lowest, Class III the highest. The class largely decides which route a device took to market, and each route produces a different kind of FDA record.

Getting the vocabulary right is also a quick credibility check. A vendor that calls a 510(k) device "FDA approved" is either being loose with language or does not know the pathway its own product took.

• •510(k) premarket notification: the manufacturer shows the device is substantially equivalent to a legally marketed predicate device. The result is a clearance, and the record number starts with K.
• •De Novo classification: for novel low- to moderate-risk devices with no suitable predicate. A granted De Novo can become the predicate for later 510(k)s. Record numbers start with DEN.
• •Premarket approval (PMA): the most stringent pathway, used for high-risk devices and supported by clinical evidence. The result is an approval, and the record number starts with P.
• •Exempt: almost all Class I and some Class II device types need no premarket submission at all. The manufacturer must still register, list the device and meet FDA's other requirements.

How to look up a device, step by step

FDA publishes its premarket decisions in public, searchable databases. Ten minutes with them will tell you more than the brochure.

Searching by product code is especially useful for capital equipment. As of September 2026, FDA's open data lists more than 1,100 510(k) clearances under the product code for MRI systems alone, which is exactly why confirming the specific model matters.

• •Ask the vendor for the exact submission number (a K, DEN or P number) and the model names it covers. A vague answer here is itself a finding.
• •Search the matching FDA database by that number, and confirm the applicant is the manufacturer you are dealing with, or a company it has acquired.
• •Read the device name and the indications for use. The record covers what was submitted, so check that your model and your intended use are within it.
• •Note the product code. It links the device to its classification, and lets you find other devices of the same type to compare against.
• •If there is no premarket record, check FDA's product classification database to see whether the device type is exempt before treating the gap as a problem.

Check that the record matches what you are actually buying

A clearance is specific: it covers the device as described in the submission, for the indications stated. Three gaps come up again and again in procurement.

• •Model and configuration. A product line can span several submissions, and the coil, accessory or software option in your quote may sit under a different record than the base system.
• •Modifications. Significant changes to a cleared device can require a new 510(k). If the vendor mentions a new hardware revision or software release, ask which record covers it.
• •Intended use. If your clinicians plan to use a device outside its cleared indications, that is a clinical and compliance decision to make deliberately, not something to discover after installation.

Look past the clearance: recalls, adverse events and warning letters

A clearance records a decision made on a particular day. What has happened since matters just as much for equipment you will rely on for years.

• •Recalls. FDA classifies recalls by hazard. Class I is the most serious, where there is a reasonable probability the product will cause serious adverse health consequences or death; Class II involves temporary or medically reversible harm; Class III is unlikely to cause adverse health consequences.
• •Adverse event reports. FDA's MAUDE database collects reports of suspected device problems. Individual reports are not verified and cannot prove a device caused an event, but a pattern is worth a question.
• •Warning letters. A warning letter about a manufacturer's quality system is a signal to ask what was found, what was fixed and when.

Put it in the contract, and keep the evidence

Due diligence should end up in writing. Work with your counsel on regulatory representations in the agreement: that the device is lawfully marketed for the stated indications, that the vendor will promptly notify you of recalls, safety communications and field actions affecting your units, and that it will maintain the regulatory status the product depends on.

Then keep the evidence with the contract: the submission numbers, a copy of each FDA record as it stood on the day you checked, and who reviewed it. When a question comes up at renewal or during an audit, you want the answer next to the agreement, not in someone's inbox.

VeloContract keeps vendor due diligence, including evidence, findings and approvals, in one auditable record alongside the contract it supports, so the checks you ran before signing are still there when you need them.