Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
QFC · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223263 | Prevena Plus 125 Therapy Unit | 3M | 2023-02-13 | 112 | 1 |
| K203716 | PICO Single Use Negative Pressure Wound Therapy System, PICO | Smith and Nephew Medical Limited | 2021-12-14 | 358 | 0 |
| DEN180013 | PREVENA 125 and PREVENA PLUS 125 Therapy Units | Kci USA, Inc. | 2019-04-19 | 400 | 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