Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GBT · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941391 | INFLATABLE RETENTION CUFF SPECULUM | Innovatec Medical Corp. | 1994-10-20 | 212 | 0 |
| K924549 | TRI-MED QUICK-STEP(TM) RECTAL TUBE | Tri-Med Specialties, Inc. | 1994-02-10 | 519 | 0 |
| K890466 | SIGMOID TONOMITOR | Tonometrics, Inc. | 1989-04-21 | 80 | 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