Cleared Traditional

K950621 - BIOFILL BIOCELLULOSE DRESSING STERILE

K950621 is an FDA 510(k) clearance for BIOFILL BIOCELLULOSE DRESSING STERILE, manufactured by The Purdue Frederick Co.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K950621 · The Purdue Frederick Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
319d
Days
Class 1
Risk

K950621 is an FDA 510(k) clearance for the BIOFILL BIOCELLULOSE DRESSING STERILE. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by The Purdue Frederick Co. (Norwalk, US). The FDA issued a Cleared decision on December 26, 1995 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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.

View all The Purdue Frederick Co. devices

FDA 510(k) Submission Details - K950621

510(k) Number K950621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1995
Decision Date December 26, 1995
Days to Decision 319 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 115d · This submission: 319d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

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 157
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K950621.
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