Cleared Traditional

K202157 - PICO 7 Single Use Negative Pressure Wou...

K202157 is the FDA 510(k) clearance for PICO 7 Single Use Negative Pressure Wou... by Smith & Nephew Medical Limited. It is a Class 2 General & Plastic Surgery device (product code OMP) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K202157 · Smith & Nephew Medical Limited · General & Plastic Surgery device
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Oct 2020
Decision
88d
Days
Class 2
Risk

K202157 is an FDA 510(k) clearance for the PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use .... Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Smith & Nephew Medical Limited (Hull, GB). The FDA issued a Cleared decision on October 30, 2020 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smith & Nephew Medical Limited devices

Submission Details

510(k) Number K202157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2020
Decision Date October 30, 2020
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 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 K202157.
Nisus Touch Negative Pressure Wound Therapy Pump
K203693 · Cork Medical Products, LLC · Aug 2021
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
PocketDoc™ Micro Wound Therapy System
K200223 · Pensar Medical, LLC · 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