# Cork Medical

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 4 (2023–2026): 4 510(k) clearances
- Product codes: OMP (4)
- 510(k) review time since 2016: median 198 days, against 161 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 4 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cork Medical Products, LLC: 2 (https://510kreport.com/company/cork-medical-products)

## Its most-cited devices
- K230677: Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) (2023), cited by 1
- K243187: Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (2025), cited by 1

## Recent decisions
- K261291: Nisus NPWT Canister 500-mL (CPC-500) (May 21, 2026)
- K243187: Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (Jun 27, 2025)
- K241061: VERSA Negative Pressure Wound Therapy System (VCMPP-100) (Aug 21, 2024)
- K230677: Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) (Dec 6, 2023)

Source page: https://510kreport.com/company/cork-medical