Cleared Traditional

K970399 - KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) (FDA 510(k) Clearance)

Class I Physical Medicine device.

K970399 · Allegiance Healthcare Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
59d
Days
Class 1
Risk

K970399 is an FDA 510(k) clearance for the KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD). Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Allegiance Healthcare Corp. (Riverside, US). The FDA issued a Cleared decision on April 3, 1997 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - 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 Allegiance Healthcare Corp. devices

Submission Details

510(k) Number K970399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date April 03, 1997
Days to Decision 59 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IMD Pack, Hot Or Cold, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5710
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.