Cleared Traditional

K802784 - ELASTIC OPEN WEAVE BANDAGE

K802784 is an FDA 510(k) clearance for ELASTIC OPEN WEAVE BANDAGE, manufactured by Secol Co.. The device is a Class 1 General Hospital device with product code FQM cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K802784 · Secol Co. · General Hospital
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Dec 1980
Decision
36d
Days
Class 1
Risk

K802784 is an FDA 510(k) clearance for the ELASTIC OPEN WEAVE BANDAGE. Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by Secol Co. (Mchenry, US). The FDA issued a Cleared decision on December 10, 1980 after a review of 36 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 Secol Co. devices

FDA 510(k) Submission Details - K802784

510(k) Number K802784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1980
Decision Date December 10, 1980
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
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 20
Devices cleared under the same product code (FQM) and FDA review panel - the closest regulatory comparables to K802784.
ROLL STRETCH GAUZE
K802991 · Abco Dealers, Inc. · Dec 1980
ELASTIC GAUZE
K802992 · Abco Dealers, Inc. · Dec 1980
ELASTIC BANDAGE
K802785 · Secol Co. · Dec 1980
TUBULAR BANDAGE
K802789 · Secol Co. · 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