Cleared Traditional

K211318 - PICO 7 Single Use Negative Pressure Wou...

K211318 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 250-day FDA review.

K211318 · Smith & Nephew Medical Limited · General & Plastic Surgery device
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Jan 2022
Decision
250d
Days
Class 2
Risk

K211318 is an FDA 510(k) clearance for the PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 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 January 5, 2022 after a review of 250 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.

View all Smith & Nephew Medical Limited devices

Submission Details

510(k) Number K211318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2021
Decision Date January 05, 2022
Days to Decision 250 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
135d slower than avg
Panel avg: 115d · This submission: 250d
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 K211318.
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
K210107 · Genadyne Biotechnologies, Inc. · Jun 2022
Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
K211571 · Zhejiang Longterm Medical Technology Co., Ltd. · May 2022
Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
K202783 · Smith & Nephew Medical Limited · Jan 2022
Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
K202898 · Lightstone Medical Products (Ningbo) Co, Ltd. · Dec 2021
3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)
K211521 · 3M Healthcare Business Group · Dec 2021
Theia NPWT Foam Wound Dressing Kit
K211277 · Clear Choice Therapeutics, Inc. · Dec 2021