Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med-Life, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K844420 | MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR | Med-Life, Inc. | 1984-12-17 | 32 | 0 |
| K821306 | HEAD-UP SUPINE SAFETY SUPPORT CUSHION | Med-Life, Inc. | 1982-06-07 | 34 | 0 |
| K821307 | ANESTHECACHE | Med-Life, Inc. | 1982-05-14 | 10 | 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