IMD · Class I · 21 CFR 890.5710

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

Leading manufacturers include Prism Technologies, Inc., Omni Therm, Inc. and Allegiance Healthcare Corp..

82
Total
82
Cleared
75d
Avg days
1976
Since
Stable submission activity - 0 submissions in the last 2 years

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 Jul 24, 2017
Infant Transport Mattress Warmer with Disc
K163295
Rapid Aid Corp.
Physical Medicine · 244d
Cleared Mar 06, 2012
NEO NEST
K112547
Denovo Proucts, LLC
Physical Medicine · 187d
Cleared Sep 11, 2008
EYEFEEL OPHTHALMIC WARMER
K082087
Bio-Lipid, Inc.
Physical Medicine · 50d
Cleared Aug 14, 2007
BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)
K071710
Johnson & Johnson Consumer Products, Inc.
Physical Medicine · 53d
Cleared Sep 03, 2002
EYEFEEL OPHTHALMIC WARMER
K021843
Bio-Lipid, Inc.
Physical Medicine · 90d
Cleared Jan 21, 1999
ALLEGIANCE PORTA-WARM MATTRESS
K982652
Allegiance Healthcare Corp.
Physical Medicine · 175d
Cleared Feb 26, 1998
DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS
K980509
Deroyal Industries, Inc.
Physical Medicine · 16d
Cleared Nov 19, 1997
CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER
K974190
Consolidated Products & Services, Inc.
Physical Medicine · 15d
Cleared Nov 13, 1997
ALLEGIANCE KWIK HEAT WARM PERINEAL PACK
K973770
Allegiance Healthcare Corp.
Physical Medicine · 42d
Cleared Apr 03, 1997
KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)
K970399
Allegiance Healthcare Corp.
Physical Medicine · 59d
Cleared Dec 12, 1996
RECOVER ADULT VEIN WARMER
K963689
Florida Medical Industries, Inc.
Physical Medicine · 87d
Cleared Nov 25, 1996
INSTANT HOT PACKS
K963768
Kick Ice, Inc.
Physical Medicine · 67d
Cleared Oct 30, 1996
INSTANT COLD PACK
K963666
Kick Ice, Inc.
Physical Medicine · 47d
Cleared Oct 10, 1996
TEMPRA COLD PACK, REORDER NO. TC150
K963220
Tempo Technology, Inc.
Physical Medicine · 55d
Cleared Sep 04, 1996
IMNI HOT PACKS
K955788
Omni Therm, Inc.
Physical Medicine · 257d
Cleared Sep 04, 1996
OMNI COLD GEL PACKS
K961176
Omni Therm, Inc.
Physical Medicine · 163d
Cleared Aug 15, 1996
ANDELA DYNAMIC COOLING DEVICE
K951033
Candela Laser Corp.
Physical Medicine · 528d
Cleared May 06, 1996
CERTI COOL INSTANT COLD COMPRESS
K960624
Certified Safety Mfg., Inc.
Physical Medicine · 83d
Cleared Feb 13, 1996
OMNI COLD GEL PACKS
K954877
Omni Therm, Inc.
Physical Medicine · 112d
Cleared Oct 31, 1995
RESTORE, THERMACELLS (HOT PACK I)
K953442
Neal Dunning Assoc., Inc.
Physical Medicine · 106d
Cleared Oct 30, 1995
COLDGEL
K953542
Prism Technologies, Inc.
Physical Medicine · 94d
Cleared Oct 05, 1995
INSTANT COLDGEL
K953541
Prism Technologies, Inc.
Physical Medicine · 69d
Cleared Aug 23, 1995
INFANT HEEL WARMER
K950680
Baxter Healthcare Corp
Physical Medicine · 190d

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 remained relatively stable over the observed period, with 0 submissions in the last 24 months.