Cleared Traditional

K831551 - COMPRESSOGRIP TUBULAR ELASTIC BANDAGE

K831551 is an FDA 510(k) clearance for COMPRESSOGRIP TUBULAR ELASTIC BANDAGE, manufactured by Fred Sammons, Inc.. The device is a Class 1 General Hospital device with product code FQM cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K831551 · Fred Sammons, Inc. · General Hospital
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Jun 1983
Decision
26d
Days
Class 1
Risk

K831551 is an FDA 510(k) clearance for the COMPRESSOGRIP TUBULAR ELASTIC BANDAGE. Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 7, 1983 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5075 - the FDA general hospital 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 Fred Sammons, Inc. devices

FDA 510(k) Submission Details - K831551

510(k) Number K831551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1983
Decision Date June 07, 1983
Days to Decision 26 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 129d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

FQM Device Classification - Class 1, General Controls

Product Code FQM Bandage, Elastic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5075
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 - FQM Bandage, Elastic

All 14
Devices cleared under the same product code (FQM) and FDA review panel - the closest regulatory comparables to K831551.
ASPEN ESMARK BANDAGE
K872868 · Aspen Laboratories, Inc. · Jul 1987
SOF-BAND HIGH STRETCH BANDAGES
K810137 · Johnson & Johnson Professionals, Inc. · Feb 1981
ROLL STRETCH GAUZE
K802991 · Abco Dealers, Inc. · Dec 1980
ELASTIC GAUZE
K802992 · Abco Dealers, Inc. · Dec 1980
ELASTIC BANDAGE CAT.#182-186 (WIDTH)
K801990 · Pollak (Intl.), Ltd. · Sep 1980
FINGER PAINGUARD CAT.#193-194
K802015 · Pollak (Intl.), Ltd. · Sep 1980