Cleared Traditional

K870185 - BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE)

K870185 is an FDA 510(k) clearance for BANDAGE, manufactured by Fraass Survival Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K870185 · Fraass Survival Systems, Inc. · General & Plastic Surgery device
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Feb 1987
Decision
21d
Days
Class 1
Risk

K870185 is an FDA 510(k) clearance for the BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE). Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Fraass Survival Systems, Inc. (Bronx, US). The FDA issued a Cleared decision on February 6, 1987 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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 Fraass Survival Systems, Inc. devices

FDA 510(k) Submission Details - K870185

510(k) Number K870185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1987
Decision Date February 06, 1987
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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 - NAD Dressing, Wound, Occlusive

All 52
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K870185.
JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING
K872982 · Johnson & Johnson Professionals, Inc. · Aug 1987
ALLEVYN HYDROPHILIC POLYURETHANE DRESSING
K871166 · Smith & Nephew, Inc. · Jun 1987
BANDAGES CATALOG NUMBER: 101 TO 220
K871495 · I M, Inc. · May 1987
DRESSING, BURN, 24 BY 36 INCHES
K870239 · Fraass Survival Systems, Inc. · Feb 1987
EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES
K864011 · Fraass Survival Systems, Inc. · Nov 1986
WOUND MANAGER(TM) - STERILE
K862935 · Convatec, A Division of E.R. Squibb & Sons · Aug 1986