Cleared Traditional

K141382 - BIOS KING BIOCELLULOSE FILM

K141382 · Coreleader Biotech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
259d
Days
-
Risk

K141382 is an FDA 510(k) clearance for the BIOS KING BIOCELLULOSE FILM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Coreleader Biotech Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on February 10, 2015 after a review of 259 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.

FDA 510(k) Submission Details - K141382

510(k) Number K141382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2014
Decision Date February 10, 2015
Days to Decision 259 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
144d slower than avg
Panel avg: 115d · This submission: 259d
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
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