Cleared Special

K180618 - PICO Single Use Negative Pressure Wound...

K180618 is the FDA 510(k) clearance for PICO Single Use Negative Pressure Wound... by Smith & Nephew Medical Limited. It is a Class 2 General & Plastic Surgery device (product code OMP) cleared through the Special 510(k) pathway after a 42-day FDA review.

K180618 · Smith & Nephew Medical Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
42d
Days
Class 2
Risk

K180618 is an FDA 510(k) clearance for the PICO Single Use Negative Pressure Wound Therapy System. 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 April 20, 2018 after a review of 42 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smith & Nephew Medical Limited devices

Submission Details

510(k) Number K180618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2018
Decision Date April 20, 2018
Days to Decision 42 days
Submission Type Special
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
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

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

Smith & Nephew
Kulsum Master

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 99
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K180618.
VT Dressing Kits
K172725 · Carilex Medical, Inc. · Jun 2018
Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
K180855 · Kci USA, Inc. · Jun 2018
Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad
K172145 · Medela AG · May 2018
PICO Single Use Negative Pressure Wound Therapy System
K180614 · Smith & Nephew Medical Limited · Apr 2018
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
K173426 · Kci USA, Inc. · Mar 2018
V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit
K173447 · Kci USA, Inc. · Mar 2018