Cleared Special

K241134 - 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)

K241134 is an FDA 510(k) clearance for 3M ActiV.A.C. Canister - 300ml with Gel..., manufactured by Kci USA, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Special 510(k) pathway after a 29-day FDA review.

K241134 · Kci USA, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
29d
Days
Class 2
Risk

K241134 is an FDA 510(k) clearance for the 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10). Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Kci USA, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 23, 2024 after a review of 29 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K241134

510(k) Number K241134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2024
Decision Date May 23, 2024
Days to Decision 29 days
Submission Type Special
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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

OMP Device Classification - Class 2, Special Controls

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 217
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K241134.
Negative Pressure Wound Therapy Device (V-Move, V-Grand)
K241023 · Med Way, Inc. · Aug 2024
NEXA™ NPWT System
K241515 · Nexa Medical Limited · Jul 2024
Renasys Edge
K231939 · Smith & Nephew Medical, Ltd. · May 2024
Prospera Spectruum Negative Pressure Wound Therapy System
K230233 · Deroyal Industries, Inc. · Apr 2024
Carilex VT¿200-i NX
K231646 · Carilex Medical, Inc. · Apr 2024
PREVENT Kit
K232379 · Clear Choice Therapeutics · Feb 2024
K241134 · 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)
Download PDF FDA Summary Kci USA, Inc.