Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dawn Medical · 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) |
|---|---|---|---|---|---|
| K933135 | DAWN DISPOSABLE BIOPSY FORCEPS | Dawn Medical | 1994-03-07 | 252 | 0 |
| K904117 | SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST. | Dawn Medical | 1991-02-25 | 172 | 0 |
| K904118 | SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST. | Dawn Medical | 1991-02-25 | 172 | 0 |
| K905733 | SEROMA-CATH CLOSE DRAINAGE SYSTEM | Dawn Medical | 1991-01-28 | 35 | 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