Cleared Traditional

K782008 - DRESSING

K782008 is an FDA 510(k) clearance for DRESSING, manufactured by Abbott Laboratories. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K782008 · Abbott Laboratories · General & Plastic Surgery device
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May 1979
Decision
164d
Days
Class 1
Risk

K782008 is an FDA 510(k) clearance for the DRESSING, ENVIRON WOUND. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 14, 1979 after a review of 164 days - an extended review 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: 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K782008

510(k) Number K782008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1978
Decision Date May 14, 1979
Days to Decision 164 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 115d · This submission: 164d
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 74
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K782008.
PREP-SITE PROTECTIVE DRESSING WIPE
K811625 · Acme United Corp. · Jul 1981
HYDRON WOUND DRESSING KIT
K811446 · National Patent Development Corp. · Jun 1981
HYDRON BURN DRESSING FIELD KIT
K791865 · National Patent Development Corp. · Nov 1979
KIMLON BEDGARD UNDERPAD
K790384 · Kimberly-Clark Corp. · Apr 1979
HYDRON BURN BANDAGE MANUAL APPLICATION
K781406 · Abbott Laboratories · Sep 1978
AEROPLAST DRESSING
K781031 · Parke-Davis Co. · Jul 1978