Cleared Traditional

K801458 - WINTER HEAD DRESSING

K801458 is the FDA 510(k) clearance for WINTER HEAD DRESSING by Steridyne Corp.. It is a Class 1 General Hospital device (product code FQM) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K801458 · Steridyne Corp. · General Hospital
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Jul 1980
Decision
34d
Days
Class 1
Risk

K801458 is an FDA 510(k) clearance for the WINTER HEAD DRESSING. Classified as Bandage, Elastic (product code FQM), Class I - General Controls.

Submitted by Steridyne Corp. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 34 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 Steridyne Corp. devices

Submission Details

510(k) Number K801458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1980
Decision Date July 28, 1980
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 15
Devices cleared under the same product code (FQM) and FDA review panel - the closest regulatory comparables to K801458.
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
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