Cleared Traditional

K871916 - FRASTEC DRY BURN DRESSING

K871916 · Fraass Survival Systems, Inc. · General & Plastic Surgery device
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Jun 1987
Decision
29d
Days
-
Risk

K871916 is an FDA 510(k) clearance for the FRASTEC DRY BURN DRESSING. Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Fraass Survival Systems, Inc. (Bronx, US). The FDA issued a Cleared decision on June 16, 1987 after a review of 29 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 - K871916

510(k) Number K871916 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 18, 1987
Decision Date June 16, 1987
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

All 156
Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K871916.
PHARMANET (TM)
K872572 · Pharmacia, Inc. · Jan 1988
EAR AND EYE SPONGES
K873831 · Ormed Mfg., Inc. · Oct 1987
AQUATULLE FINE MESH NON-ADHERING DRESSING
K872759 · Smith & Nephew, Inc. · Sep 1987
FRASTEC DRY GAUZE BANDAGE
K871917 · Fraass Survival Systems, Inc. · Jun 1987
BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52
K871438 · Fraass Survival Systems, Inc. · May 1987
SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES
K864175 · Fraass Survival Systems, Inc. · Nov 1986