Cleared Traditional

K203716 - PICO Single Use Negative Pressure Wound Therapy System, 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 (FDA 510(k) Clearance)

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

K203716 · Smith and Nephew Medical Limited · General & Plastic Surgery device
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Dec 2021
Decision
358d
Days
Class 2
Risk

K203716 is an FDA 510(k) clearance for the PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Neg.... Classified as Negative Pressure Wound Therapy Device For Reduction Of Wound Complications (product code QFC), Class II - Special Controls.

Submitted by Smith and Nephew Medical Limited (Hull, GB). The FDA issued a Cleared decision on December 14, 2021 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4783 - 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. Elevated predicate reliance profile. 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 K203716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2020
Decision Date December 14, 2021
Days to Decision 358 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
244d slower than avg
Panel avg: 114d · This submission: 358d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QFC Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4783
Definition A Negative Pressure Wound Therapy Device For Reduction Of Wound Complications Is A Powered Suction Pump Intended For Wound Management And Reduction Of Wound Complications Via Application Of Negative Pressure To The Wound, Which Removes Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. This Device Type Is Intended For Use With Wound Dressings Classified Under 21 Cfr 878.4780. This Classification Does Not Include Devices Intended For Organ Space Wounds.
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.