Cleared Traditional

K800195 - COTTON UNDER CAST PADDING (FDA 510(k) Clearance)

Class I Physical Medicine device.

K800195 · Winn Hirsch & Assoc. · Physical Medicine device
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Feb 1980
Decision
13d
Days
Class 1
Risk

K800195 is an FDA 510(k) clearance for the COTTON UNDER CAST PADDING. Classified as Bandage, Cast (product code ITG), Class I - General Controls.

Submitted by Winn Hirsch & Assoc. (Mchenry, US). The FDA issued a Cleared decision on February 11, 1980 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3025 - the FDA physical medicine 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 Winn Hirsch & Assoc. devices

Submission Details

510(k) Number K800195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1980
Decision Date February 11, 1980
Days to Decision 13 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ITG Bandage, Cast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3025
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.