Cleared Traditional

K802015 - FINGER PAINGUARD CAT.#193-194

K802015 is an FDA 510(k) clearance for FINGER PAINGUARD CAT.#193-194, manufactured by Pollak (Intl.), Ltd.. The device is a Class 1 General Hospital device with product code FQM cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K802015 · Pollak (Intl.), Ltd. · General Hospital
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Sep 1980
Decision
20d
Days
Class 1
Risk

K802015 is an FDA 510(k) clearance for the FINGER PAINGUARD CAT.#193-194. Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by Pollak (Intl.), Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980 after a review of 20 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 Pollak (Intl.), Ltd. devices

FDA 510(k) Submission Details - K802015

510(k) Number K802015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1980
Decision Date September 09, 1980
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
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 K802015.
ELASTIC OPEN WEAVE BANDAGE
K802784 · Secol Co. · Dec 1980
TUBULAR BANDAGE
K802789 · Secol Co. · Dec 1980
ELASTIC BANDAGE CAT.#182-186 (WIDTH)
K801990 · Pollak (Intl.), Ltd. · Sep 1980
ANAGO DISP., ALL PURPOSE PATIENT REST.
K800197 · Anago, Inc. · Feb 1980
BINDAFIX
K791211 · Conphar, Inc. · Aug 1979
SECUTEX SURGICAL BINDER
K791256 · Conphar, Inc. · Aug 1979