Cleared Traditional

K870184 - BANDAGE

K870184 · Fraass Survival Systems, Inc. · General & Plastic Surgery device
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Feb 1987
Decision
21d
Days
-
Risk

K870184 is an FDA 510(k) clearance for the BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES. Classified as Dressing, Wound, Drug (product code FRO).

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. 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

Submission Details

510(k) Number K870184 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
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 224
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K870184.
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · Smith & Nephew, Inc. · Jul 1987
CUTINOVA(R) PLUS FOAM GELFILM
K864913 · Beiersdorf, Inc. · Jul 1987
AMERICAN PHARMASEAL WOUND DRESSING
K871770 · American Pharmaseal Div. Ahsc · Jun 1987
VISCOPASTE ZINC PASTE BANDAGE
K863930 · Smith & Nephew, Inc. · Dec 1986
CHESEBROUGH POND'S HYDROCOLLOID DRESSING
K862803 · Chesebrough-Pond'S U.S.A. Co. · Nov 1986
HYDROCOLLOID DRESSINGS - STERILE
K863390 · Convatec, A Division of E.R. Squibb & Sons · Sep 1986