Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Talley Medical · 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) |
|---|---|---|---|---|---|
| K090258 | VENTURI NPWT V. II ADVANCED VACUUM SYSTEM | Talley Medical | 2009-08-25 | 204 | 0 |
| K080897 | VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM | Talley Medical | 2008-07-15 | 106 | 0 |
| K080763 | TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL | Talley Medical | 2008-05-30 | 73 | 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