Cleared Traditional

K960624 - CERTI COOL INSTANT COLD COMPRESS

K960624 is an FDA 510(k) clearance for CERTI COOL INSTANT COLD COMPRESS, manufactured by Certified Safety Mfg., Inc.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K960624 · Certified Safety Mfg., Inc. · Physical Medicine device
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May 1996
Decision
83d
Days
Class 1
Risk

K960624 is an FDA 510(k) clearance for the CERTI COOL INSTANT COLD COMPRESS. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on May 6, 1996 after a review of 83 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 Certified Safety Mfg., Inc. devices

FDA 510(k) Submission Details - K960624

510(k) Number K960624 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 13, 1996
Decision Date May 06, 1996
Days to Decision 83 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 115d · This submission: 83d
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 22
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K960624.
ALLEGIANCE KWIK HEAT WARM PERINEAL PACK
K973770 · Allegiance Healthcare Corp. · Nov 1997
KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)
K970399 · Allegiance Healthcare Corp. · Apr 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
CERTI HEAT INSTANT HEAT COMPRESS
K940336 · Certified Safety Mfg., Inc. · Mar 1994