IMD · Class I · 21 CFR 890.5710

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

Leading manufacturers include Anago, Inc., Allegiance Healthcare Corp. and The Kendal Co..

Total

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 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 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 Aug 15, 1996

ANDELA DYNAMIC COOLING DEVICE

K951033

Candela Laser Corp.

Physical Medicine · 528d

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 26, 1993

ANAGO FEM-COOL/FEM-COOL PETITE

K926137

Anago, Inc.

Physical Medicine · 170d

Physical Medicine · 170d

Cleared May 26, 1993

ANAGO DISPOSABLE INSTANT COLD PACK

K926590

Anago, Inc.

Physical Medicine · 170d

Cleared Feb 11, 1992

CURAD KID SIZE INSTANT COLD PACK

K920252

Kendall Healthcare Products Co. Div.Of Tyco Health

Physical Medicine · 21d

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

Cleared Mar 26, 1981

CURITY PERINEAL WARM PACK

K810692

The Kendal Co.

Physical Medicine · 13d

Cleared Mar 26, 1981

CURITY PERINEAL COLD PACK

K810693

The Kendal Co.

Physical Medicine · 13d

Physical Medicine · 11d

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.

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

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

About Product Code IMD - Regulatory Context

510(k) Submission Activity

Related FDA 510(k) Regulatory Insights