Cleared Traditional

K200223 - PocketDoc Micro Wound Therapy System

K200223 is the FDA 510(k) clearance for PocketDoc Micro Wound Therapy System by Pensar Medical, LLC. It is a Class 2 General & Plastic Surgery device (product code OMP) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K200223 · Pensar Medical, LLC · General & Plastic Surgery device
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Oct 2020
Decision
268d
Days
Class 2
Risk

K200223 is an FDA 510(k) clearance for the PocketDoc™ Micro Wound Therapy System. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Pensar Medical, LLC (Norco, US). The FDA issued a Cleared decision on October 23, 2020 after a review of 268 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 K200223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2020
Decision Date October 23, 2020
Days to Decision 268 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
153d slower than avg
Panel avg: 115d · This submission: 268d
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

Acknowledge Regulatory Strategies, LLC
Pierre Bounaud

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 100
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K200223.
Avance Solo Negative Pressure Wound Therapy (NPWT) System
K203369 · Molnlycke Health Care Us, LLC · Jul 2021
Kendall NPWT Incision Management Device
K202217 · Cardinalhealth · Jun 2021
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack
K202157 · Smith & Nephew Medical Limited · Oct 2020
Kendall NPWT Incision Management Dressing Kit
K191101 · Cardinalhealth · Jul 2020
ACTIV.A.C. Negative Pressure Wound Therapy System
K201571 · Kci USA, Inc. · Jul 2020
V.A.C. DERMATAC Drape
K200390 · Kci USA, Inc. · May 2020