Cleared Traditional

K905207 - MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS (FDA 510(k) Clearance)

Class I Physical Medicine device.

K905207 · Micro Surgical Instruments Corp. · Physical Medicine device
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Jan 1991
Decision
63d
Days
Class 1
Risk

K905207 is an FDA 510(k) clearance for the MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS. Classified as Pack, Hot Or Cold, Reusable (product code IME), Class I - General Controls.

Submitted by Micro Surgical Instruments Corp. (Valencia, US). The FDA issued a Cleared decision on January 22, 1991 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5700 - 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 Micro Surgical Instruments Corp. devices

Submission Details

510(k) Number K905207 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 20, 1990
Decision Date January 22, 1991
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IME Pack, Hot Or Cold, Reusable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5700
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.