Cleared Traditional

Applied Tissue Technologies PWD™ Platform Wound Dressing (K182409) - FDA 510(k) Clearance

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

K182409 · Applied Tissue Technologies, LLC · General & Plastic Surgery device
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Jan 2019
Decision
129d
Days
Class 2
Risk

K182409 is an FDA 510(k) clearance for the Applied Tissue Technologies PWD™ Platform Wound Dressing. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Applied Tissue Technologies, LLC (Hingham, US). The FDA issued a Cleared decision on January 11, 2019 after a review of 129 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 Applied Tissue Technologies, LLC devices

Submission Details

510(k) Number K182409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2018
Decision Date January 11, 2019
Days to Decision 129 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
14d slower than avg
Panel avg: 115d · This submission: 129d
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

Lakeshore Medical Device Consulting, LLC
Michele Lucey

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 92
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K182409.
PREVENA RESTOR(TM) Incision Management System
K181507 · Kci USA, Inc. · Feb 2019
Invia Abdominal Dressing Kit
K182191 · Medela AG · Feb 2019
PICO 7Y Single Use Negative Pressure Wound Therapy System
K182323 · Smith & Nephew Medical Limited · Jan 2019
RENASYS Y-Connector
K181204 · Smith & Nephew Medical Limited · Jan 2019
UNO Negative Pressure Wound Therapy System
K180840 · Genadyne Biotechnologies, Inc. · Nov 2018
Invia White Foam NPWT
K180415 · Medela AG · Nov 2018