Cleared Traditional

K953542 - COLDGEL

K953542 is an FDA 510(k) clearance for COLDGEL, manufactured by Prism Technologies, Inc.. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K953542 · Prism Technologies, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
94d
Days
Class 1
Risk

K953542 is an FDA 510(k) clearance for the COLDGEL. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Prism Technologies, Inc. (Washington, US). The FDA issued a Cleared decision on October 30, 1995 after a review of 94 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 Prism Technologies, Inc. devices

FDA 510(k) Submission Details - K953542

510(k) Number K953542 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 28, 1995
Decision Date October 30, 1995
Days to Decision 94 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
21d faster than avg
Panel avg: 115d · This submission: 94d
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 32
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K953542.
ANDELA DYNAMIC COOLING DEVICE
K951033 · Candela Laser Corp. · Aug 1996
CERTI COOL INSTANT COLD COMPRESS
K960624 · Certified Safety Mfg., Inc. · May 1996
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