Cleared Traditional

OMIDERM WOUND & BURN DRESSING (K851885) - FDA 510(k) Clearance

K851885 · Biosystems Assoc. · General & Plastic Surgery device
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Nov 1985
Decision
209d
Days
-
Risk

K851885 is an FDA 510(k) clearance for the OMIDERM WOUND & BURN DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Biosystems Assoc. (La Jolla, US). The FDA issued a Cleared decision on November 25, 1985 after a review of 209 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 Biosystems Assoc. devices

Submission Details

510(k) Number K851885 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 30, 1985
Decision Date November 25, 1985
Days to Decision 209 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 115d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K851885.
NON-ADHERING DRESSING WITH POVIDONE-IODINE
K861384 · Johnson & Johnson Professionals, Inc. · Jul 1986
BARD ABSORPTION DRESSING
K861024 · C.R. Bard, Inc. · Apr 1986
ACTISORB ACTIVATED CHARCOAL DRESSING
K860486 · Johnson & Johnson Professionals, Inc. · Mar 1986
TEGADERM PLUS TRANSPARENT DRESSING #952X
K852750 · 3M Company · Sep 1985
BAND-AID BRAND ADHESIVE BANDAGES
K852545 · Johnson & Johnson Professionals, Inc. · Sep 1985
BARD OCCLUSIVE WOUND DRESSING
K850889 · C.R. Bard, Inc. · Jul 1985