Cleared Traditional

K914842 - GAUZE BANDAGE ROLL

K914842 is the FDA 510(k) clearance for GAUZE BANDAGE ROLL by Cal West Trading Co.. It is a Class 1 General & Plastic Surgery device (product code NAB) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K914842 · Cal West Trading Co. · General & Plastic Surgery device
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Dec 1991
Decision
37d
Days
Class 1
Risk

K914842 is an FDA 510(k) clearance for the GAUZE BANDAGE ROLL. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Cal West Trading Co. (Santa Fe Springs, US). The FDA issued a Cleared decision on December 4, 1991 after a review of 37 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.

View all Cal West Trading Co. devices

Submission Details

510(k) Number K914842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1991
Decision Date December 04, 1991
Days to Decision 37 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 10
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K914842.
TRICOTEX WOUND CONTACT LAYER DRESSING
K864264 · Smith & Nephew, Inc. · Dec 1986
FEMORAL CANAL SPONGE
K831886 · Zimmer, Inc. · Sep 1983
MELOLIN
K821246 · Smith & Nephew, Inc. · Aug 1982
UNIFLEX
K820470 · Howmedica Corp. · Jun 1982
HOLLISTER ODOR ABSORBING WOUND PAD
K820464 · Hollister, Inc. · Mar 1982
TRIANGULAR BANDAGE
K811814 · Abco Dealers, Inc. · Jul 1981