Cleared Traditional

K791211 - BINDAFIX

K791211 is an FDA 510(k) clearance for BINDAFIX, manufactured by Conphar, Inc.. The device is a Class 1 General Hospital device with product code FQM cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K791211 · Conphar, Inc. · General Hospital
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Aug 1979
Decision
32d
Days
Class 1
Risk

K791211 is an FDA 510(k) clearance for the BINDAFIX. Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 32 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 Conphar, Inc. devices

FDA 510(k) Submission Details - K791211

510(k) Number K791211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1979
Decision Date August 03, 1979
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
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 K791211.
ELASTIC BANDAGE CAT.#182-186 (WIDTH)
K801990 · Pollak (Intl.), Ltd. · Sep 1980
FINGER PAINGUARD CAT.#193-194
K802015 · Pollak (Intl.), Ltd. · Sep 1980
ANAGO DISP., ALL PURPOSE PATIENT REST.
K800197 · Anago, Inc. · Feb 1980
SECUTEX SURGICAL BINDER
K791256 · Conphar, Inc. · Aug 1979
TAPE, ELASTOPLAST ELASTIC TEAR
K781931 · Beiersdorf, Inc. · Dec 1978
BANDAGE
K780606 · Abco Dealers, Inc. · Apr 1978