Cleared Traditional

K254160 - VacHeal Negative Pressure Wound Therapy System

K254160 is an FDA 510(k) clearance for VacHeal Negative Pressure Wound Therapy..., manufactured by VacHeal, LLC. The device is a Class 2 General & Plastic Surgery device with product code OKO cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K254160 · VacHeal, LLC · General & Plastic Surgery device
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Sep 2026
Decision
270d
Days
Class 2
Risk

K254160 is an FDA 510(k) clearance for the VacHeal Negative Pressure Wound Therapy System. Classified as Negative Pressure Wound Therapy Non-powered Suction Apparatus (product code OKO), Class II - Special Controls.

Submitted by VacHeal, LLC (Ardmore, US). The FDA issued a Cleared decision on September 18, 2026 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 878.4683 - 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 VacHeal, LLC devices

FDA 510(k) Submission Details - K254160

510(k) Number K254160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2025
Decision Date September 18, 2026
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
155d slower than avg
Panel avg: 115d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OKO Device Classification - Class 2, Special Controls

Product Code OKO Negative Pressure Wound Therapy Non-powered Suction Apparatus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4683
Definition A Non-powered Suction Apparatus Indicated For Negative Pressure Wound Therapy (npwt) That Is Intended 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.
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 - OKO Negative Pressure Wound Therapy Non-powered Suction Apparatus

All 17
Devices cleared under the same product code (OKO) and FDA review panel - the closest regulatory comparables to K254160.
NPseal
K251156 · Guard Medical, Inc. · May 2025
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K250708 · Guard Medical, Inc. · Apr 2025
NPseal (20 and 25)
K241522 · Guard Medical, Inc. · Aug 2024
NPseal (Small, Medium, Large)
K240244 · Guard Medical, Inc. · Feb 2024
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K212971 · Guard Medical, Inc. · Feb 2022
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K211130 · Guard Medical, Inc. · May 2021