Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FEM — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940152 | CAMERA COVER WITH TEAR TIP | Hydro-Med Products, Inc. | 1994-10-28 | 298 | 0 |
| K812542 | POLAROID INSTANT ENDOCAMERA | Polaroid Corp. | 1981-10-19 | 45 | 0 |
| K812201 | PHOTOGRAPHIC EQUIPMENT | Reznik Instruments | 1981-10-19 | 76 | 0 |
| K792512 | POLAROID LAND CAMERA FOR ENDOSCOPY | Polaroid Corp. | 1979-12-20 | 15 | 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