Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Devon Medical Products — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161209 | Cirona 6400 | Devon Medical Products | 2016-05-31 | 33 | 0 |
| K151189 | Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention | Devon Medical Products | 2015-09-18 | 137 | 0 |
| K151240 | extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, e | Devon Medical Products | 2015-06-09 | 29 | 0 |
| K143362 | extriCARE 3600 Negative Pressure Wound Therapy System 1000cc | Devon Medical Products | 2015-02-03 | 71 | 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