Cleared Traditional

K100613 - BIOMED WOUND CLEANSER

K100613 · Biomed Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
307d
Days
-
Risk

K100613 is an FDA 510(k) clearance for the BIOMED WOUND CLEANSER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Biomed Laboratories, Inc. (Garland, US). The FDA issued a Cleared decision on January 5, 2011 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K100613

510(k) Number K100613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2010
Decision Date January 05, 2011
Days to Decision 307 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
192d slower than avg
Panel avg: 115d · This submission: 307d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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K100613 · BIOMED WOUND CLEANSER
Download PDF FDA Summary Biomed Laboratories, …