The summary is public. The statement isn't.

Every cleared 510(k) satisfies the same disclosure requirement one of two ways, and the choice belongs to the applicant, not FDA. 21 CFR 807.92 describes a 510(k) summary: enough detail about the device and the basis for substantial equivalence that FDA can post it publicly on its own initiative. 21 CFR 807.93 describes the alternative — a 510(k) statement, a short certification that the applicant will hand the same underlying data to anyone who asks. Two documents doing the same regulatory job, with opposite defaults on who ever sees the substance behind a clearance.

What a statement actually promises

21 CFR 807.93 is specific about what the certifier is on the hook for: all of the safety and effectiveness information in the original submission, made available within 30 days of a request — a duplicate of the filing itself, adverse findings included, with only patient identifiers and confidential commercial information withheld. Nothing in the regulation requires FDA to hold or forward that data. The obligation sits with the company that cleared the device, and it activates only if a specific person asks for it.

What FDA Radar’s own clearance record carries

openFDA’s 510(k) endpoint returns a field for exactly this choice — statement_or_summary — on every record, and FDA Radar’s ingestion reads it off the raw payload for every clearance it fetches. It does not currently carry that value into the facts a reader sees: not the K-number’s title, not its source text, not the structured fields a future watchlist would query. The distinction this post describes comes from FDA’s own field reference and the regulation behind it — not from anything FDA Radar surfaces about a specific clearance today.

A summary is a document you can read. A statement is a promise you have to collect on — and nothing in the public record says which one you’re looking at.

The practice

Before treating a competitor’s or a predicate’s K-number as fully documented because a 510(k) summary turned up in a search, confirm it actually is one. A statement-route clearance carries no public summary at all — only the certification, and the fact of clearance itself. If the safety-and-effectiveness basis matters to a predicate decision, 807.93 gives a path to it: a written request to the applicant, with a thirty-day clock the regulation puts on them, not on FDA. What that basis should mean for a specific predicate or submission is a judgment for a regulatory professional working the file — this is regulatory intelligence about which of two documents a clearance produced, per FDA Radar’s editorial standards, never advice about when to invoke the request yourself.