Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FMA · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
32 daysmedian FDA review time
161 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992995 | AROMATIC AND FLAVORED TONGUE DEPRESSOR | Aga Plastic Ind. Com. Ltda. | 1999-12-09 | 93 | 0 |
| K842461 | TONGUE DEPRESSOR | The Torrent Corp. | 1984-11-30 | 161 | 0 |
| K830705 | MINI LANCET-BLOOD LANCET | Pharmaquest Corp. | 1983-04-08 | 32 | 0 |
| K821177 | BITE STICK | Abco Dealers, Inc. | 1982-05-21 | 24 | 0 |
| K770120 | MOUTH WASH TRAY | Pharmaseal Div., Baxter Healthcare Corp. | 1977-01-28 | 7 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda