Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Talley Group, Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
170 daysmedian FDA review time
442 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151263 | Venturi Gauze Wound Care Sets with Portal Drain | Talley Group, Ltd. | 2016-02-19 | 282 | 0 |
| K143004 | VENTURI MiNO TG600/14 | Talley Group, Ltd. | 2016-01-05 | 442 | 0 |
| K914775 | TALLEY MICRO SYSTEM/TALLEY RIPPLEBED | Talley Group, Ltd. | 1992-04-10 | 170 | 0 |
| K914774 | MULTIPULSE SEQUENTIAL COMPRESSION UNIT | Talley Group, Ltd. | 1992-02-11 | 111 | 0 |
| K914780 | TALLEY SD.500 SKIN PRESSURE EVALUATOR | Talley Group, Ltd. | 1991-12-19 | 57 | 0 |
| K914776 | OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR | Talley Group, Ltd. | 1991-12-19 | 57 | 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