Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stat Medical Corp. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K780171 | ELBOW PROTECTOR | Stat Medical Corp. | 1978-02-06 | 4 | 0 |
| K771030 | FLEXION MITTENS | Stat Medical Corp. | 1977-06-27 | 18 | 0 |
| K771031 | STROKE SLING | Stat Medical Corp. | 1977-06-27 | 18 | 0 |
| K770853 | STERILE COTTON | Stat Medical Corp. | 1977-05-23 | 14 | 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