Cleared Traditional

K970399 - KWIK KOLD PERI COLD PACK (CATALOG NUMBE...

K970399 is an FDA 510(k) clearance for KWIK KOLD PERI COLD PACK (CATALOG NUMBE..., manufactured by Allegiance Healthcare Corp.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 59-day FDA review.

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

FDA 510(k) Submission Details - K970399

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

IMD Device Classification - Class 1, General Controls

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.

Regulatory Peers - IMD Pack, Hot Or Cold, Disposable

All 20
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K970399.
ALLEGIANCE PORTA-WARM MATTRESS
K982652 · Allegiance Healthcare Corp. · Jan 1999
DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS
K980509 · Deroyal Industries, Inc. · Feb 1998
ALLEGIANCE KWIK HEAT WARM PERINEAL PACK
K973770 · Allegiance Healthcare Corp. · Nov 1997
ANDELA DYNAMIC COOLING DEVICE
K951033 · Candela Laser Corp. · Aug 1996
INFANT HEEL WARMER
K950680 · Baxter Healthcare Corp · Aug 1995
POLY-MEDICS HEAT PACK
K941245 · Biomet, Inc. · May 1994