Cleared Traditional

K935948 - CONVATEC TWO PIECE ABSORBENT DRESSING S...

K935948 is the FDA 510(k) clearance for CONVATEC TWO PIECE ABSORBENT DRESSING S... by Convatec, A Division of E.R. Squibb & Sons. It is a Class 1 General & Plastic Surgery device (product code KGX) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K935948 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
78d
Days
Class 1
Risk

K935948 is an FDA 510(k) clearance for the CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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

Submission Details

510(k) Number K935948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1993
Decision Date March 01, 1994
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 70
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K935948.
STERILE PLASTIC DRESSING
K944588 · Smith & Nephew, Inc. · Nov 1994
EMPI TAPE PATCHES
K941389 · Empi · Aug 1994
COVERLET ADHESIVE DRESSING
K940378 · Beiersdorf, Inc. · Jul 1994
EPISEAL ADHESIVE WOUND CLOSURE STRIPS
K935725 · Deroyal Industries, Inc. · Feb 1994
3M TEGADERM HP TRANSPARENT DRESSING
K932422 · 3M Health Care, Ltd. · Dec 1993
BIOCLUSIVE MVP TRANSPARENT DRESSING
K923235 · Johnson & Johnson Medical, Inc. · May 1993