Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tagg Industries · 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) |
|---|---|---|---|---|---|
| K021849 | TAGG DISPOSABLE VAGINAL SPECULUM | Tagg Industries | 2002-07-16 | 41 | 0 |
| K946225 | 3M FILTRETE(TM) AIR FILTER MEDIA | Tagg Industries | 1995-05-25 | 164 | 0 |
| K864472 | PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK | Tagg Industries | 1987-01-12 | 60 | 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