Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Traumafuse Co. — 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) |
|---|---|---|---|---|---|
| K895162 | TRAUMAFUSE TRACH SHIELD | The Traumafuse Co. | 1990-01-09 | 140 | 0 |
| K894721 | TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE | The Traumafuse Co. | 1989-10-20 | 87 | 0 |
| K895132 | CONNELL-STEPHENS ENDO ANESS TUBE | The Traumafuse Co. | 1989-10-13 | 57 | 0 |
| K890077 | TRAUMAFUSE RAPID INFUSION DEVICE | The Traumafuse Co. | 1989-04-03 | 84 | 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