Cleared Traditional

FORYOU NPWT DEVICE (K113236) - FDA 510(k) Clearance

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

K113236 · Foryou Medical Electronics Co, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
468d
Days
Class 2
Risk

K113236 is an FDA 510(k) clearance for the FORYOU NPWT DEVICE. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Foryou Medical Electronics Co, Ltd. (Murrysville, US). The FDA issued a Cleared decision on February 12, 2013 after a review of 468 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 878.4780 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Foryou Medical Electronics Co, Ltd. devices

Submission Details

510(k) Number K113236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2011
Decision Date February 12, 2013
Days to Decision 468 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
353d slower than avg
Panel avg: 115d · This submission: 468d
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 211
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K113236.
RENASYS EDGE (66803126)
K260646 · Smith & Nephew Medical, Ltd. · May 2026
Nisus NPWT Canister 500-mL (CPC-500)
K261291 · Cork Medical · May 2026
Wound Geni NPWT System
K254019 · Bechtel Medical, Inc. · May 2026
Genadyne ASTRA NPWT
K253429 · Genadyne Biotechnologies, Inc. · Mar 2026
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
K250586 · Deroyal Industries, Inc. · Nov 2025
extriCARE® 1000 Negative Pressure Wound Therapy System
K251646 · Alleva Medical Devices · Oct 2025