Cleared Traditional

K243187 - Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243187 · Cork Medical · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 2025
Decision
270d
Days
Class 2
Risk

K243187 is an FDA 510(k) clearance for the Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100). Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Cork Medical (Indianapolis, US). The FDA issued a Cleared decision on June 27, 2025 after a review of 270 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K243187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date June 27, 2025
Days to Decision 270 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 114d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMP Negative Pressure Wound Therapy Powered Suction Pump
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
Definition For Wound Management Via Application Of Continual Or Intermittent Negative Pressure To The Wound For Removal Of Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. The Device Is Indicated For Management Of Chronic, Acute, Traumatic, Subacute And Dehisced Wounds, Partial-thickness Burns, Ulcers (such As Diabetic Or Pressure), Flaps And Grafts.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OMP Negative Pressure Wound Therapy Powered Suction Pump

All 208
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K243187.
Genadyne ASTRA NPWT
K253429 · Genadyne Biotechnologies, Inc. · Mar 2026
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
K250586 · Deroyal Industries, Inc. · Nov 2025
extriCARE® 1000 Negative Pressure Wound Therapy System
K251646 · Alleva Medical Devices · Oct 2025
RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
K251826 · Smith & Nephew Medical, Ltd. · Sep 2025
RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port
K243576 · Smith & Nephew Medical, Ltd. · Feb 2025
Genadyne DUO NPWT
K233614 · Genadyne Biotechnologies, Inc. · Dec 2024