Atlas FDA

IMD

82 FDA 510(k) clearances · Product code

49 daysmedian time to decision
170 days90th percentile
82clearances measured

FDA profile

Official device name
Pack, Hot Or Cold, Disposable
Device class
Class I (low risk)
Regulation
21 CFR 890.5710
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2021: 142 · 2022: 202 · 2023: 184 · 2024: 112 · 2025: 66 · 2026: 156
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
InfaTherm Disposable Infant Warming Mattress (K221653)International Biomedical2022-10-06
Infant Transport Mattress Warmer with Disc (K163295)Rapid Aid Corp.2017-07-24
NEO NEST (K112547)Denovo Proucts, LLC2012-03-06
EYEFEEL OPHTHALMIC WARMER (K082087)Bio-Lipid, Inc.2008-09-11
BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) (K071710)Johnson & Johnson Consumer Products, Inc.2007-08-14
EYEFEEL OPHTHALMIC WARMER (K021843)Bio-Lipid, Inc.2002-09-03
ALLEGIANCE PORTA-WARM MATTRESS (K982652)Allegiance Healthcare Corp.1999-01-21
DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS (K980509)Deroyal Industries, Inc.1998-02-26
CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER (K974190)Consolidated Products & Services, Inc.1997-11-19
ALLEGIANCE KWIK HEAT WARM PERINEAL PACK (K973770)Allegiance Healthcare Corp.1997-11-13
KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) (K970399)Allegiance Healthcare Corp.1997-04-03
RECOVER ADULT VEIN WARMER (K963689)Florida Medical Industries, Inc.1996-12-12
INSTANT HOT PACKS (K963768)Kick Ice, Inc.1996-11-25
INSTANT COLD PACK (K963666)Kick Ice, Inc.1996-10-30
TEMPRA COLD PACK, REORDER NO. TC150 (K963220)Tempo Technology, Inc.1996-10-10
OMNI COLD GEL PACKS (K961176)Omni Therm, Inc.1996-09-04
IMNI HOT PACKS (K955788)Omni Therm, Inc.1996-09-04
ANDELA DYNAMIC COOLING DEVICE (K951033)Candela Laser Corp.1996-08-15
CERTI COOL INSTANT COLD COMPRESS (K960624)Certified Safety Mfg., Inc.1996-05-06
OMNI COLD GEL PACKS (K954877)Omni Therm, Inc.1996-02-13
RESTORE, THERMACELLS (HOT PACK I) (K953442)Neal Dunning Assoc., Inc.1995-10-31
COLDGEL (K953542)Prism Technologies, Inc.1995-10-30
INSTANT COLDGEL (K953541)Prism Technologies, Inc.1995-10-05
INFANT HEEL WARMER (K950680)Baxter Healthcare Corp1995-08-23
TEMPRA HEAT PACK (K951383)Tempra Technology, Inc.1995-06-01
POLY-MEDICS HEAT PACK (K941245)Biomet, Inc.1994-05-02
OMNI WARM GEL PACKS (K936084)Omni Therm, Inc.1994-03-31
CERTI HEAT INSTANT HEAT COMPRESS (K940336)Certified Safety Mfg., Inc.1994-03-07
INSTANT HOT OR COLD DISPOSABLE PACK (K935569)Cryopak Industries, Inc.1994-03-07
TRANSWARMER (K934631)Prism Technologies, Inc.1994-02-03
KACEY DISPOSABLE INFANT HEEL WARMER (K934673)K & C Medical, Inc.1994-02-02
PERI-K PAD COLD PACK (K920760)Baxter Healthcare Corp1993-07-29
ANAGO FEM-COOL/FEM-COOL PETITE (K926137)Anago, Inc.1993-05-26
ANAGO DISPOSABLE INSTANT COLD PACK (K926590)Anago, Inc.1993-05-26
ANAGO WARM PACK (K926589)Anago, Inc.1993-05-26
CURAD KID SIZE INSTANT COLD PACK (K920252)Kendall Healthcare Products Co. Div.Of Tyco Health1992-02-11
INSTANT WARM GEL PACK (K912715)Prism Technologies, Inc.1991-10-02
SHUR-LOCK ICE WRAP SYSTEM (K904819)Conco Medical Co.1990-12-06
LIBERTY HOT PACK AND LIBERTY KOLD PACK (K902839)Liberty Ent.1990-07-25
INSTANT ICE PACK (K901834)Impact Packaging Corp.1990-05-03
3M HEAT COMFORT PORTABLE SELF-HEATING PAD (K901778)3M Company1990-05-01
MEDI-PACK (K895860)Heatmax Mfg., Inc.1990-01-02
STAT-PAD (K894926)Hettel Accessories, Inc.1989-09-05
THERMO-PACK (K890924)Medical Manufacturers, Inc.1989-03-14
CP&S DISPOSABLE INSTANT COLD COMPRESS (K890553)Consolidated Products & Services, Inc.1989-02-13
CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS (K890554)Consolidated Products & Services, Inc.1989-02-13
HARE COLD PACK (K883966)Dyna Industries, Inc.1988-09-30
GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER (K880871)John Wagner Associates, Inc.1988-05-20
HYPERTHERM TECHNOLOGIES' HEAT COMPRESS (K873364)Hypertherm Technologies, Inc.1987-11-17
INSTANT COLD COMPRESS, CHEMICAL TYPE (K871168)Lexington Industries1987-04-06
INSTANT HEAT COMPRESS, CHEMICAL TYPE (K871114)Lexington Industries1987-03-25
OXY-THERM (K870832)M.D. Intl., Inc.1987-03-12
PHYSI. & NURSES BRAND INSTANT KOLD & HOT KOMPRESS (K863507)Physician & Nurses Mfg. Corp.1986-09-19
MAZING HEAT DISPOSABLE WARM PACK (K860444)Leebryan Intl.1986-02-27
HOT OR HEAT PACK (K853148)Matrix Intl.1985-09-25
ALLY PORTABLE NOT PACK/PAD DISPOSABLE (K853045)Actin International, Inc.1985-09-06
HOT PACK (K852610)Oriental Medical Supplies, Inc.1985-08-12
MARUKYR-BAN / HOT OR HEAT PACK (K850566)Oriental Medical Supplies, Inc.1985-05-29
EXOTHERMIC HEATING PAD (K850637)Travenol Laboratories, S.A.1985-04-25
EIXO THERMUS HEATING PADS (K844224)Eixo Thermus1984-11-23
SPENCO CRYOPRESS (K820906)Spenco Medical Corp.1982-05-13
COMPRES PORTABLE HEAT PADS (K821046)S.C. Johnson & Son, Inc.1982-04-29
HOT MINI 15 & HOT MINI 24 (K820359)Hot Mini International, Inc.1982-03-08
ACE BRAND INSTANT COLD PACK (K820282)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-02-12
BK-7182 INSTANT COLD PACK (K813628)Fred Sammons, Inc.1982-01-19
JAPANESE HOTZIE (K811803)Consolidated Health & Sports Prod.1981-07-31
SELF HEATING DISPOSABLE HEAT PAD (K811206)Ensar Corp.1981-05-21
WONDER WARMER (K810633)Montvale Products, Inc.1981-03-26
CURITY PERINEAL WARM PACK (K810692)The Kendal Co.1981-03-26
CURITY PERINEAL COLD PACK (K810693)The Kendal Co.1981-03-26
HOT CYCLE, A CHEMICAL TYPE HOT PACK (K802252)Signal West1980-10-03
INSTANT HOT & COLD PACKS (K790993)Chase Mfg. Co.1979-09-07
KWICK KOOLER (K791675)Stahlex Corp.1979-09-04
TULANE HEAT-PACK (K790480)Tulane1979-04-03
BODY WARMER (K780426)Q-Matic Corp.1978-04-27
COLD PACK (K780603)Abco Dealers, Inc.1978-04-21
ICE-PAK, PDI (K780279)Nice-Pak Products, Inc.1978-04-10
COLD CYCLE, CHEMICAL COLD PACK (K780014)Signal West1978-02-21
KWICK KOOLER (K771660)World Trade Assoc.1977-11-07
SHAKE-N-WARM (K770505)Signal West1977-04-05
MUL-T-PAD (K760706)Gaymar Industries, Inc.1976-10-06
BODY WARMER (SHAKE-N-WARM) (K760441)Yamada Co., Ltd of Japan1976-09-16

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Every clearance here is in the API, with alerts when new ones post.