Cleared Traditional

K942270 - SAF-GEL HYDRATING DERMAL WOUND DRESSING

K942270 is an FDA 510(k) clearance for SAF-GEL HYDRATING DERMAL WOUND DRESSING, manufactured by Calgon Vestal Div.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K942270 · Calgon Vestal Div. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
86d
Days
Class 1
Risk

K942270 is an FDA 510(k) clearance for the SAF-GEL HYDRATING DERMAL WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Calgon Vestal Div. (St. Louis, US). The FDA issued a Cleared decision on August 4, 1994 after a review of 86 days - a notably fast clearance cycle.

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: 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 Calgon Vestal Div. devices

FDA 510(k) Submission Details - K942270

510(k) Number K942270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1994
Decision Date August 04, 1994
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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 89
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K942270.
DERMAGRAN HYDROPHILIC OINTMENT
K944491 · Derma Sciences, Inc. · Nov 1994
CURADERM ALGINATE HYDROCOLLOID
K943636 · Kendall Healthcare Products Co. Div.Of Tyco Health · Oct 1994
CAVI-CARE CONFORMING FOAM DRESSING
K943619 · Smith & Nephew United, Inc. · Aug 1994
HYDROCOLLOID WOUND DRESSING
K943258 · Convatec, A Division of E.R. Squibb & Sons · Aug 1994
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