You can verify an FDA-related claim on a connected diagnostic device yourself, using two free public databases: the Product Classification Database, which shows a device’s regulatory category, and the matching authorization database (510(k), PMA, or De Novo), which shows whether a specific product was actually reviewed. Comparing what you find against the marketing claim tells you whether the wording holds up.
What “FDA cleared” and similar claims on a connected diagnostic device actually mean
Before searching any database, write down the exact phrase used in the claim — “registered,” “classified,” “cleared,” or “approved” are not interchangeable, even though sellers often use them as if they were:
- “FDA registered” or “FDA listed” — the company has registered its facility and listed a device with the FDA. This is an administrative step, not a review of safety or effectiveness.
- “FDA classified” — the device falls into an existing product category (Class I, II, or III) with an assigned product code. Classification describes regulatory risk category, not a product-specific approval.
- “FDA cleared” (510(k)) — the FDA reviewed a premarket notification and found the device “substantially equivalent” to a legally marketed device. This is the most common pathway for moderate-risk (Class II) devices.
- “FDA approved” (PMA) — the FDA reviewed clinical and manufacturing data and approved the device, typically for higher-risk (Class III) devices. This is a higher bar than clearance.
The FDA’s own guidance on determining device status evaluates a product against the legal device definition, then matches it to an existing classification or a specific review pathway. A claim of “FDA approved” attached to a device that was actually only classified, not approved, is a mismatch worth investigating.
A four-step process for checking the record
Each step below builds on the last. Do them in order — skipping the classification step is the most common reason people can’t find a match later.
- Identify the exact product name and manufacturer. Database searches work on exact or close-to-exact product names, manufacturer names, or product codes. Look for the full product name and the company holding the FDA submission, which is sometimes different from the consumer-facing brand.
- Search the Product Classification Database. Search by keyword, then try device-type synonyms if the first search returns nothing — a “digital otoscope” might sit under a broader ear-examination device category. This step confirms whether the device type has an existing classification and risk class, not whether this specific product was reviewed.
- Check for a specific authorization record. Classification is not the same as authorization. Search the 510(k) database for most Class II clearances, the PMA database for most Class III approvals, or the De Novo database for novel low-to-moderate risk devices without an existing equivalent. Search by product name or manufacturer and open any record you find.
- Compare the intended use statement to the marketing claim. Every classification or authorization record includes an intended use statement — what the device is meant to do and, where relevant, for what condition or population. Read it line by line against the product’s actual marketing copy.
Decision path: what to do with what you find
If you find a specific authorization record, compare its intended use statement word for word against the marketing claim — a mismatch in scope (general screening versus diagnosis of a specific condition) matters even when both get marketed with similar language. If you find no authorization record at all, don’t assume the claim is false: check the classification database first, since many Class I and some Class II devices are legally exempt from premarket review and will never appear in the clearance databases.
Common questions this process raises
Is FDA clearance the same as FDA approval?
No. Clearance (510(k)) means the FDA has found a device to be substantially equivalent to one already on the market, typically for Class II devices. Approval (PMA) means the FDA reviewed clinical and manufacturing data directly, typically for higher-risk Class III devices. The two terms describe different pathways and different levels of review.
What does it mean if I can’t find the product in any FDA database?
Many Class I devices, and some Class II devices, are exempt from premarket review and legitimately won’t appear in the 510(k), PMA, or De Novo databases even when legally marketed. Absence from those two databases alone isn’t proof of anything — check the classification database to see if the device type is exempt before drawing a conclusion.
Does a classification or clearance match mean the device is safe and effective for me personally?
No. A record confirms a regulatory pathway was followed for a general intended use — it doesn’t evaluate an individual reader’s situation. It is not a substitute for guidance from a qualified clinician about a specific health concern.
What if the company name on the record doesn’t match the brand I saw advertised?
This happens when a product is manufactured or distributed under a different legal entity than the consumer-facing brand. Before concluding a claim is unsupported, search the database using any manufacturer or distributor names listed in the product’s own packaging, documentation, or terms of use.
How often are these FDA databases updated?
The Product Classification Database’s underlying files are updated every Sunday. Authorization databases are updated on their own schedules as new decisions are issued, so a very recent authorization may take some time to appear.
What this process cannot tell you
This method verifies whether a specific regulatory claim is documented in a public database. It cannot tell you whether a product will work well for your situation, whether it’s the right tool for a health concern you’re facing, or whether a company’s other claims — accuracy percentages, comparative statements, user results — are accurate; those require separate verification against their own sources. If you’re facing an urgent health concern, use this process only after, never instead of, contacting a healthcare provider or emergency services.
This article is educational information about public FDA regulatory databases and does not constitute medical, legal, or regulatory advice. Everyday Imaging Evidence is an independent editorial publication and is not affiliated with, and does not speak on behalf of, the FDA or any device manufacturer. See our full medical information disclaimer for more. For guidance on a specific product or health decision, consult the manufacturer’s own regulatory documentation, a qualified healthcare provider, or the FDA directly.
Reviewed September 2026. For more on how this publication verifies its sources, see our How We Research page or start with our Start Here guide. Spot an error in this guide? Our corrections process explains how to report it.
By Everyday Imaging Evidence Editorial Team
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