Cleared Traditional

K935569 - INSTANT HOT OR COLD DISPOSABLE PACK

K935569 is an FDA 510(k) clearance for INSTANT HOT OR COLD DISPOSABLE PACK, manufactured by Cryopak Industries, Inc.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K935569 · Cryopak Industries, Inc. · Physical Medicine device
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Mar 1994
Decision
109d
Days
Class 1
Risk

K935569 is an FDA 510(k) clearance for the INSTANT HOT OR COLD DISPOSABLE PACK. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Cryopak Industries, Inc. (Canada, CA). The FDA issued a Cleared decision on March 7, 1994 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Cryopak Industries, Inc. devices

FDA 510(k) Submission Details - K935569

510(k) Number K935569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1993
Decision Date March 07, 1994
Days to Decision 109 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 115d · This submission: 109d
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 35
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K935569.
OMNI COLD GEL PACKS
K954877 · Omni Therm, Inc. · Feb 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
PERI-K PAD COLD PACK
K920760 · Baxter Healthcare Corp · Jul 1993
ANAGO FEM-COOL/FEM-COOL PETITE
K926137 · Anago, Inc. · May 1993