Cleared Traditional

K870241 - COMPRESS AND BANDAGE, VARIOUS SIZES

K870241 · Fraass Survival Systems, Inc. · General & Plastic Surgery device
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Feb 1987
Decision
16d
Days
-
Risk

K870241 is an FDA 510(k) clearance for the COMPRESS AND BANDAGE, VARIOUS SIZES. 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 16 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

FDA 510(k) Submission Details - K870241

510(k) Number K870241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1987
Decision Date February 06, 1987
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 529
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K870241.
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BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES
K870184 · Fraass Survival Systems, Inc. · Feb 1987
FERRIS DYNADERM PLUS
K865089 · Ferris Mfg. Corp. · Feb 1987
VISCOPASTE ZINC PASTE BANDAGE
K863930 · Smith & Nephew, Inc. · Dec 1986
LYOFOAM C ODOR-ABSORBING DRESSING
K864084 · Acme United Corp. · Nov 1986