Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FAX · Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950125 | KARL STORZ BOUGIES AND DILATORS | KARL STORZ Endoscopy-America, Inc. | 1995-02-07 | 26 | 0 |
| K822711 | ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL | Parker Laboratories, Inc. | 1982-11-03 | 57 | 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