Cleared Traditional

K912715 - INSTANT WARM GEL PACK

K912715 is an FDA 510(k) clearance for INSTANT WARM GEL PACK, 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 106-day FDA review.

K912715 · Prism Technologies, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1991
Decision
106d
Days
Class 1
Risk

K912715 is an FDA 510(k) clearance for the INSTANT WARM GEL PACK. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Prism Technologies, Inc. (Chicago, US). The FDA issued a Cleared decision on October 2, 1991 after a review of 106 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 - K912715

510(k) Number K912715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1991
Decision Date October 02, 1991
Days to Decision 106 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
9d faster than avg
Panel avg: 115d · This submission: 106d
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 K912715.
ANAGO WARM PACK
K926589 · Anago, Inc. · May 1993
ANAGO DISPOSABLE INSTANT COLD PACK
K926590 · Anago, Inc. · May 1993
CURAD KID SIZE INSTANT COLD PACK
K920252 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1992
3M HEAT COMFORT PORTABLE SELF-HEATING PAD
K901778 · 3M Company · May 1990
EXOTHERMIC HEATING PAD
K850637 · Travenol Laboratories, S.A. · Apr 1985
ACE BRAND INSTANT COLD PACK
K820282 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1982