Cleared Traditional

K920252 - CURAD KID SIZE INSTANT COLD PACK

K920252 is an FDA 510(k) clearance for CURAD KID SIZE INSTANT COLD PACK, manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 1 Physical Medicine device with product code IMD cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K920252 · Kendall Healthcare Products Co. Div.Of Tyco Health · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
21d
Days
Class 1
Risk

K920252 is an FDA 510(k) clearance for the CURAD KID SIZE INSTANT COLD PACK. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on February 11, 1992 after a review of 21 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K920252

510(k) Number K920252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1992
Decision Date February 11, 1992
Days to Decision 21 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
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 K920252.
ANAGO FEM-COOL/FEM-COOL PETITE
K926137 · Anago, Inc. · May 1993
ANAGO WARM PACK
K926589 · Anago, Inc. · May 1993
ANAGO DISPOSABLE INSTANT COLD PACK
K926590 · Anago, Inc. · May 1993
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