Cleared is not approved

“FDA approved” shows up on device marketing copy, investor decks, and competitor teardown slides often enough that it reads as a synonym for FDA cleared it, whichever term the writer reached for first. It isn’t a synonym. It is a specific, defined finding that most devices on the market never received — and for a device that only has the other finding, FDA’s own rule gives the swap a name: misbranding.

Two findings, not two words for one finding

A 510(k) clearance is FDA agreeing that a device is substantially equivalent to a predicate already on the market — the standard Congress set in section 513(i)(1)(A) of the FD&C Act, built to move a device through on a comparison rather than a from-scratch safety-and-effectiveness case. A PMA approval is a different finding entirely: under 21 CFR 814.44, FDA issues an order approving the application once it determines the submission contains sufficient valid scientific evidence to support reasonable assurance the device is safe and effective for its intended use — the standard reserved for Class III devices, where general and special controls are judged insufficient on their own. Substantial equivalence to something already out there, and an independent finding of safety and effectiveness, are not the same review, and clearance and approval are not the same word for having passed one.

The rule that names the specific swap

This isn’t a style preference FDA would rather manufacturers observe. 21 CFR 807.97 addresses it directly, and says a 510(k) clearance “does not in any way denote official approval of the device,” then goes further: “Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.” That is the exact shape of the common error — not a factual overstatement about performance, but a word substitution that borrows the credibility of a review the device never went through.

Clearance and approval sit on different legal footing, not just different vocabulary. One rule makes the distinction; the mistake is treating it as two words for the same outcome.

Where “approved” is the accurate word instead

The word isn’t forbidden — it is exact, for a narrower set of devices than most readers assume. 21 CFR Part 814 governs premarket approval, and it is the minority pathway by volume: most devices reaching the market clear through 510(k), and PMA is reserved for the highest-risk Class III category and devices with no predicate to compare against. A device that genuinely holds a PMA number earned the word “approved” the way the rule defines it. A device holding only a K number didn’t, no matter how the marketing copy reads.

What one radar covers, and what it doesn’t

FDA Radar’s own clearance corpus is built on openFDA’s 510(k) endpoint alone — K numbers, applicants, product codes, decision dates, per what we monitor and how often. A device’s PMA history sits in a separate FDA database this radar doesn’t currently walk, which means a competitor’s approval record isn’t part of what this product-code matching can confirm or rule out. That is a boundary worth knowing before reading silence here as an answer about a device’s approval status one way or the other — the 510(k) corpus can tell you a device cleared; it was never built to tell you a different device was approved.

The practice

Read a claim of “FDA approved” against the record before taking it at face value, on a competitor’s device, a supplier’s component, or a draft of your own marketing copy. A K number in the record means clearance, precisely, and the accurate word for it. Whether a specific piece of copy crosses into the misbranding 807.97 describes is a judgment about specific language on a specific claim — regulatory intelligence and method, never regulatory advice, and one for counsel or a regulatory professional reading the exact words in front of them.