Cleared Traditional

K840107 - TUBE-BANDAGE FOR HUMAN DIGITS 200

K840107 is an FDA 510(k) clearance for TUBE-BANDAGE FOR HUMAN DIGITS 200, manufactured by Zens Health Care Products. The device is a Class 1 General Hospital device with product code FQM cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K840107 · Zens Health Care Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
106d
Days
Class 1
Risk

K840107 is an FDA 510(k) clearance for the TUBE-BANDAGE FOR HUMAN DIGITS 200. Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by Zens Health Care Products (Walker, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 106 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Zens Health Care Products devices

FDA 510(k) Submission Details - K840107

510(k) Number K840107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1984
Decision Date April 25, 1984
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 129d · This submission: 106d
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 15
Devices cleared under the same product code (FQM) and FDA review panel - the closest regulatory comparables to K840107.
ASPEN ESMARK BANDAGE
K872868 · Aspen Laboratories, Inc. · Jul 1987
COMPRESSOGRIP TUBULAR ELASTIC BANDAGE
K831551 · Fred Sammons, Inc. · Jun 1983
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