Cleared Traditional

TUBE-BANDAGE FOR HUMAN DIGITS 200 (K840107) - FDA 510(k) Clearance

Class I General Hospital device.

K840107 · Zens Health Care Products · General Hospital
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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

Submission Details

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.

Device Classification

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 8
Devices cleared under the same product code (FQM) and FDA review panel - the closest regulatory comparables to K840107.
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
BINDAFIX
K791211 · Conphar, Inc. · Aug 1979
SECUTEX SURGICAL BINDER
K791256 · Conphar, Inc. · Aug 1979