Cleared Traditional

K192463 - PHMB Foam Dressing Non-Adhesive

K192463 · Winner Medical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
248d
Days
-
Risk

K192463 is an FDA 510(k) clearance for the PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB F.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Winner Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 14, 2020 after a review of 248 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Winner Medical Co., Ltd. devices

FDA 510(k) Submission Details - K192463

510(k) Number K192463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2019
Decision Date May 14, 2020
Days to Decision 248 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 115d · This submission: 248d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 227
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K192463.
HaloGUARD Protective Disc with CHG
K200641 · Attwill Medical Solutions · Sep 2020
LT Antibacterial Alginate with Silver Dressing
K192478 · Zhejiang Longterm Medical Technology Co., Ltd. · Jun 2020
Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border
K191819 · Winner Medical Co., Ltd. · May 2020
PuraDERM Gel
K193085 · 3-D Matrix, Inc. · May 2020
AC5 Topical Gel
K190129 · Arch Therapeutics, Inc. · Mar 2020
Biatain Silicone Ag
K191536 · Coloplast A/S · Feb 2020