Cleared Traditional

K251646 - extriCARE® 1000 Negative Pressure Wound Therapy System (FDA 510(k) Clearance)

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

K251646 · Alleva Medical Devices · General & Plastic Surgery device
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Oct 2025
Decision
127d
Days
Class 2
Risk

K251646 is an FDA 510(k) clearance for the extriCARE® 1000 Negative Pressure Wound Therapy System. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Alleva Medical Devices (Brea, US). The FDA issued a Cleared decision on October 3, 2025 after a review of 127 days - within the typical 510(k) review window.

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.

View all Alleva Medical Devices devices

Submission Details

510(k) Number K251646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2025
Decision Date October 03, 2025
Days to Decision 127 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
13d slower than avg
Panel avg: 114d · This submission: 127d
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 Consultant

Addwin Consulting
Mona Advani

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K251646.
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
RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
K251826 · Smith & Nephew Medical, Ltd. · Sep 2025
Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
K243187 · Cork Medical · Jun 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