Cleared Traditional

K800197 - ANAGO DISP.

K800197 is an FDA 510(k) clearance for ANAGO DISP., manufactured by Anago, Inc.. The device is a Class 1 General Hospital device with product code FQM cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K800197 · Anago, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1980
Decision
27d
Days
Class 1
Risk

K800197 is an FDA 510(k) clearance for the ANAGO DISP., ALL PURPOSE PATIENT REST.. Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by Anago, Inc. (Walker, US). The FDA issued a Cleared decision on February 26, 1980 after a review of 27 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 Anago, Inc. devices

FDA 510(k) Submission Details - K800197

510(k) Number K800197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1980
Decision Date February 26, 1980
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
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 K800197.
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
BINDAFIX
K791211 · Conphar, Inc. · Aug 1979
SECUTEX SURGICAL BINDER
K791256 · Conphar, Inc. · Aug 1979
TAPE, ELASTOPLAST ELASTIC TEAR
K781931 · Beiersdorf, Inc. · Dec 1978