Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Team Mfg., 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) |
|---|---|---|---|---|---|
| K922055 | STERILE AND NON-STERILE GAUZE SPONGES | Team Mfg., Inc. | 1992-08-10 | 98 | 0 |
| K922054 | STERILE GAUZE SPONGES X-RAY DETECTABLE | Team Mfg., Inc. | 1992-08-10 | 98 | 0 |
| K904934 | AUTOMASTER | Team Mfg., Inc. | 1991-05-21 | 201 | 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