Cleared Traditional

K925004 - ALLKARE BARRIER WIPE

K925004 is the FDA 510(k) clearance for ALLKARE BARRIER WIPE by Convatec, A Division of E.R. Squibb & Sons. It is a Class 1 General & Plastic Surgery device (product code KMF) cleared through the Traditional 510(k) pathway after a 467-day FDA review.

K925004 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
467d
Days
Class 1
Risk

K925004 is an FDA 510(k) clearance for the ALLKARE BARRIER WIPE. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on January 12, 1994 after a review of 467 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K925004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1992
Decision Date January 12, 1994
Days to Decision 467 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
352d slower than avg
Panel avg: 115d · This submission: 467d
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 68
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K925004.
HYPERTONIC SALINE WET DRESSING - STERILE
K941999 · Trinity Laboratories, Inc. · Jun 1994
CURASALT HYPERTONIC SALINE DRESSING
K942459 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jun 1994
3M TEGASORB HYDROCOLLOID DRESSING
K940624 · 3M Company · May 1994
EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN
K926230 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSING
K933689 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1993
DUODERM EXTRA THIN CGF DRESSING
K925990 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993