Cleared Traditional

K150256 - SILVERLON BURN CONTACT DRESSINGS

K150256 · Argentum Medical · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
86d
Days
-
Risk

K150256 is an FDA 510(k) clearance for the SILVERLON BURN CONTACT DRESSINGS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Argentum Medical (Geneva, US). The FDA issued a Cleared decision on April 30, 2015 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K150256

510(k) Number K150256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2015
Decision Date April 30, 2015
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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 638
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K150256.
Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
K143335 · Roosin Medical Devices Co., Ltd. · Jun 2015
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K141863 · Puricore, Inc. · May 2015
DERMAFINE
K140905 · Invado Pharmaceuticals · May 2015
IPM Wound Gel Bio, IPM Derm Gel Bio
K143527 · Glycobiosciences, Inc. · Apr 2015
LUOFUCON SILVER FOAM DRESSING
K141619 · Huizhou Foryou Medical Devices Co., Ltd. · Apr 2015
LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING
K140954 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2015