510(k) Report

FDA applicant

Cork Medical

Indianapolis, IN4 decisions2023–20260 recalls

FDA records 4 decisions for Cork Medical (Indianapolis, IN) from 2023 to 2026: 4 510(k) clearances. All are in product code OMP (Negative Pressure Wound Therapy Powered…). Since 2016 its 510(k)s took a median of 198 days from receipt to decision, against 161 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Cork Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 12024: 12025: 12026 (partial year): 1
2023high 1 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Cork Medical by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OMPNegative Pressure Wound Therapy Powered Suction Pump4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 198 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 161 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K230677Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)Cork Medical · 20231cites it
  • K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)Cork Medical · 20251cites it

What has FDA decided for it lately?

  • K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical · 2026
  • K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)Cork Medical · 2025
  • K241061VERSA Negative Pressure Wound Therapy System (VCMPP-100)Cork Medical · 2024
  • K230677Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)Cork Medical · 2023

All 4 as Cork Medical →

Other applicant names beginning “Cork”

FDA records each applicant name separately; these may or may not be the same firm.

Cork Medical Products, LLC 2