Cleared Traditional

K923846 - BURN DRESSING

K923846 is an FDA 510(k) clearance for BURN DRESSING, manufactured by Medical Action Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAB cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K923846 · Medical Action Industries, Inc. · General & Plastic Surgery device
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Sep 1992
Decision
42d
Days
Class 1
Risk

K923846 is an FDA 510(k) clearance for the BURN DRESSING. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Medical Action Industries, Inc. (Farmingdale, US). The FDA issued a Cleared decision on September 11, 1992 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4014 - 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.

FDA 510(k) Submission Details - K923846

510(k) Number K923846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1992
Decision Date September 11, 1992
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

NAB Device Classification - Class 1, General Controls

Product Code NAB Gauze / Sponge,nonresorbable For External Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4014
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 - NAB Gauze / Sponge,nonresorbable For External Use

All 87
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K923846.
CLINISORB
K923115 · Hermitage Hospital Products, Inc. · Nov 1992
COMBINE II WETPROOF PAD
K923116 · Hermitage Hospital Products, Inc. · Oct 1992
USP TYPE VII GAUZE SPONGES
K923378 · E.W.A., Ltd. · Oct 1992
MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZES
K915821 · Kerma Medical Products, Inc. · May 1992
PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE
K920282 · Trinity Laboratories, Inc. · May 1992
TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE
K921227 · Courtaulds Fibers, Inc. · May 1992
K923846 · BURN DRESSING
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