Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cork Medical · 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) |
|---|---|---|---|---|---|
| K261291 | Nisus NPWT Canister 500-mL (CPC-500) | Cork Medical | 2026-05-21 | 31 | 0 |
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Cork Medical | 2025-06-27 | 270 | 0 |
| K241061 | VERSA Negative Pressure Wound Therapy System (VCMPP-100) | Cork Medical | 2024-08-21 | 125 | 0 |
| K230677 | Cork Medical VERSA Negative Pressure Wound System (VCMPP-100 | Cork Medical | 2023-12-06 | 271 | 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