Cleared Traditional

K182733 - Rochal Bioshield Silicone Film

K182733 is the FDA 510(k) clearance for Rochal Bioshield Silicone Film by Rochal Industries, LLC. It is a Class 1 General & Plastic Surgery device (product code KMF) cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K182733 · Rochal Industries, LLC · General & Plastic Surgery device
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Jun 2019
Decision
272d
Days
Class 1
Risk

K182733 is an FDA 510(k) clearance for the Rochal Bioshield Silicone Film. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Rochal Industries, LLC (San Antonio, US). The FDA issued a Cleared decision on June 27, 2019 after a review of 272 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - 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. 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 Rochal Industries, LLC devices

Submission Details

510(k) Number K182733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date June 27, 2019
Days to Decision 272 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
157d slower than avg
Panel avg: 115d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMF Bandage, Liquid

All 57
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K182733.
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K040779 · Hollister, Inc. · May 2004
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ASKINA HYDROCOLLOID/THIN
K973227 · B.Braun Medical, Inc. · Jan 1999