IMD · Class I · 21 CFR 890.5710

FDA Product Code IMD: Pack, Hot Or Cold, Disposable

Leading manufacturers include Baxter Healthcare Corp, International Biomedical and Fred Sammons, Inc..

82
Total
82
Cleared
75d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Pack, Hot Or Cold, Disposable Devices (Product Code IMD)

82 devices
1–24 of 82
Cleared Oct 06, 2022
InfaTherm Disposable Infant Warming Mattress
K221653
International Biomedical
Physical Medicine · 121d
Cleared Aug 23, 1995
INFANT HEEL WARMER
K950680
Baxter Healthcare Corp
Physical Medicine · 190d
Cleared May 02, 1994
POLY-MEDICS HEAT PACK
K941245
Biomet, Inc.
Physical Medicine · 48d
Cleared Jul 29, 1993
PERI-K PAD COLD PACK
K920760
Baxter Healthcare Corp
Physical Medicine · 526d
Cleared May 01, 1990
3M HEAT COMFORT PORTABLE SELF-HEATING PAD
K901778
3M Company
Physical Medicine · 14d
Cleared Apr 25, 1985
EXOTHERMIC HEATING PAD
K850637
Travenol Laboratories, S.A.
Physical Medicine · 65d
Cleared Feb 12, 1982
ACE BRAND INSTANT COLD PACK
K820282
Bd Becton Dickinson Vacutainer Systems Preanalytic
Physical Medicine · 10d
Cleared Jan 19, 1982
BK-7182 INSTANT COLD PACK
K813628
Fred Sammons, Inc.
Physical Medicine · 21d

About Product Code IMD - Regulatory Context

510(k) Submission Activity

82 total 510(k) submissions under product code IMD since 1976, with 82 receiving FDA clearance (average review time: 75 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.