Product Code: FMZ FDA class 2 21 CFR 880.5400

Incubator, Neonatal

General Hospital

The Neonatal Incubator is a device that provides a controlled, enclosed environment for premature or ill newborns, regulating temperature, humidity, and oxygen levels to support physiological stability during intensive care. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FMZ, regulated under 21 CFR 880.5400 in the General Hospital specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FMZ
Device Class: FDA class 2
Regulation Number: 880.5400
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 85 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251619	Babyleo TN500	Feb 13, 2026	Substantially Equivalent	Drägerwerk AG & Co. KGaA
K251663	Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)	Oct 22, 2025	Substantially Equivalent	Datex-Ohmeda, Inc.
K243437	mOm Essential Incubator (ME1)	Aug 14, 2025	Substantially Equivalent	Mom Incubators Limited
K213553	Giraffe Incubator Carestation CS1	Mar 02, 2022	Substantially Equivalent	Datex Ohmeda, Inc.
K190494	Infant Incubator	Nov 25, 2019	Substantially Equivalent	Ningbo David Medical Device Co., Ltd.
K182859	Babyleo TN500	Feb 22, 2019	Substantially Equivalent	Dragerwerk AG & CO Kgaa
K182977	Isolette 8000 Plus	Nov 21, 2018	Substantially Equivalent	Draeger Medical Systems, Inc.
K172154	Isolette 8000 plus	Apr 19, 2018	Substantially Equivalent	Draeger Medical Sytems, Inc.
K162821	Babyleo TN500	Jun 23, 2017	Substantially Equivalent	Draegerwerk AG & CO Kgaa
K152814	Giraffe OmniBed Carestation CS1	Mar 17, 2016	Substantially Equivalent	Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company
K152809	Giraffe Incubator Carestation CS1	Dec 31, 2015	Substantially Equivalent	Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
K132543	INFANT INCUBATOR	Jul 03, 2014	Substantially Equivalent	Bistos Co., Ltd.
K102226	DUAL INCU I	Jan 04, 2011	Substantially Equivalent	Atom Medical Corporation
K102279	INCU I	Dec 29, 2010	Substantially Equivalent	Atom Medical Corporation
K102710	NEO-SERVO I	Dec 22, 2010	Substantially Equivalent	Atom Medical Corporation
K101788	GIRAFFE OMNIBED	Jul 21, 2010	Substantially Equivalent	Ohmeda Medical
K101778	GIRAFFE INCUBATOR	Jul 21, 2010	Substantially Equivalent	Ohmeda Medical
K071977	TARRY MEDICAL TEMPERATURE PROBES	May 23, 2008	Substantially Equivalent	Tarry Medical Products, Inc.
K072512	MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)	Oct 03, 2007	Substantially Equivalent	Datex-Ohmeda, Inc.
K070291	MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX	Sep 21, 2007	Substantially Equivalent	Medix I.C.S.A.
K071175	OHMEDA MEDICAL GIRAFFE OMNIBED	Jul 17, 2007	Substantially Equivalent	GE Healthcare
K061856	V-2200 INFANT INCUBATOR	Sep 28, 2006	Substantially Equivalent	Atom Medical, Inc.
K053399	VERSALET 7700 CARE CENTER	Aug 04, 2006	Substantially Equivalent	Draeger Medical Infant Care, Inc.
K061280	V-2200 INFANT INCUBATOR	Jun 27, 2006	Substantially Equivalent	Neoforce Group, Inc.
K040910	INFANT INCUBATOR, MODEL CHS-I1000	Apr 21, 2004	Substantially Equivalent	Choong Wae Medical Corp.
K040068	BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM	Apr 16, 2004	Substantially Equivalent	Ohmeda Medical
K031387	ISOLETTE INFANT INCUBATOR, MODEL C2000E	Aug 01, 2003	Substantially Equivalent	Hill-Rom Manufacturing, Inc.
K021809	V-2100G ADVANCED INFANT INCUBATOR	Jul 18, 2002	Substantially Equivalent	Atom Medical Corp
K020547	OHMEDA MEDICAL GIRAFFE INCUBATOR	May 09, 2002	Substantially Equivalent	Ohmeda Medical
K020543	OHMEDA MEDICAL GIRAFFE OMNIBED	May 09, 2002	Substantially Equivalent	Ohmeda Medical
K010222	OHMEDA MEDICAL GIRAFFE INCUBATOR	Mar 21, 2001	Substantially Equivalent	Ohmeda Medical
K003067	CALEO	Dec 13, 2000	Substantially Equivalent	Drager Medizintechnik GmbH
K001242	ISOLETTE INFANT INCUBATOR, MODEL C2HS	Jul 13, 2000	Substantially Equivalent	Hill-Rom Air-Shields
K993051	VERSALET 7700 CARE CENTER, MODEL # 7700	Feb 03, 2000	Substantially Equivalent	Hill-Rom Air-Shields
K993407	OHMEDA MEDICAL OMNIBED	Jan 05, 2000	Substantially Equivalent	Ohmeda Medical
K993712	BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM	Nov 09, 1999	Substantially Equivalent	Ohmeda Medical
K980886	BABYTHERM 8000 LDR	May 29, 1998	Substantially Equivalent	Draeger Medical, Inc.
K974349	OHMEDA-OHIO CARE PLUS INCUBATOR	Feb 12, 1998	Substantially Equivalent	Ohmeda Medical
K954204	DRAGER INCUBATOR 8000 IC	Apr 25, 1997	Substantially Equivalent	Drager, Inc.
K962806	OHMEDA-OHIO CAE PLUS INCUBATOR	Sep 20, 1996	Substantially Equivalent	Ohmeda Medical
K960980	ISOLETTE INFANT INCUBATOR	Jul 30, 1996	Substantially Equivalent	Air-Shields, Inc.
K943360	OHIO CARE PLUS INCUBATOR	Sep 29, 1994	Substantially Equivalent	Ohmeda Medical
K940975	C450/C400 INFANT INCUBATORS	Jun 23, 1994	Substantially Equivalent	Air-Shields, Inc.
K924324	K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE	Nov 12, 1993	Substantially Equivalent	K-1 Medical Products, Inc.
K922618	BOWRON	Aug 19, 1993	Substantially Equivalent	G.L. Bowron & Co. , Ltd.
K920049	MEDIX PC-305 NEONATAL INCUBATOR	May 21, 1993	Substantially Equivalent	Medix I.C.S.A.
K924297	DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER	Mar 18, 1993	Substantially Equivalent	Air-Shields Vickers, Inc.
K924170	ISOLETTE INCUBATOR HUMIDITY METER	Feb 05, 1993	Substantially Equivalent	Air-Shields, Inc.
K912000	TYPE INTERFACE 9271/1 INCUBATOR/WARMER	Sep 21, 1992	Substantially Equivalent	S & W Medico Teknik
K915752	FIRST TOUCH/VILEDON NON-WOVEN FILTER	Sep 17, 1992	Substantially Equivalent	First Touch Disposables, Inc.
K914864	MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR	Mar 13, 1992	Substantially Equivalent	Air-Shields, Inc.
K914487	OHIO CARE PLUS INCUBATOR	Dec 18, 1991	Substantially Equivalent	Ohmeda Medical
K914134	INCUBATOR 8000 SC	Nov 22, 1991	Substantially Equivalent	National Draeger, Inc.
K913394	INCUBATOR 8000 IC	Nov 22, 1991	Substantially Equivalent	Dragerwerk AG
K913291	MODEL C386 ISOLETTE(R) INFANT INCUBATOR	Nov 13, 1991	Substantially Equivalent	Air-Shields, Inc.
K912909	SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM	Nov 05, 1991	Substantially Equivalent	Air-Shields Vickers, Inc.
K912910	C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM	Oct 30, 1991	Substantially Equivalent	Air-Shields Vickers, Inc.
K913154	OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION	Sep 13, 1991	Substantially Equivalent	Ohmeda Medical
K901157	MP4, MP4SI, IT4 INCUBATORS	Mar 27, 1991	Substantially Equivalent	Mediprema
K903378	MODEL C286 ISOLETTE INFANT INCUBATOR	Oct 15, 1990	Substantially Equivalent	Air-Shields Vickers, Inc.
K900752	INCUBATOR 8000	Aug 02, 1990	Substantially Equivalent	Dragerwerk AG
K901585	OHMEDA - OHIO(R) CARE PLUS INCUBATOR	Jun 22, 1990	Substantially Equivalent	Ohmeda Medical
K900735	MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR	May 02, 1990	Substantially Equivalent	Preemicare Corp.
K895782	NEONATAL INCUBATOR (ACCESSORY)	Dec 07, 1989	Substantially Equivalent	Air-Shields Vickers, Inc.
K895550	K-1 INFANT TRANSPORT SYSTEM	Dec 07, 1989	Substantially Equivalent	K-1 Medical Products, Inc.
K890476	ADEL - MODEL 986 INFANT WARMER	Jun 16, 1989	Substantially Equivalent	Adel Medical , Ltd.
K881476	PREEMICARE MODEL D1-X1, SERIES 3000	Dec 08, 1988	Substantially Equivalent	Preemicare Corp.
K884086	C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR	Nov 14, 1988	Substantially Equivalent	Air-Shields Vickers, Inc.
K870223	AMEDA AMELETTE(R) NEONATAL INCUBATOR	Jun 10, 1987	Substantially Equivalent	Hollister, Inc.
K870222	AMEDA AMECARE(R) NEONATAL INCUBATOR	Jun 10, 1987	Substantially Equivalent	Hollister, Inc.
K871399	OHIO(R) CARE PLUS INCUBATOR	Jun 05, 1987	Substantially Equivalent	Ohmeda Medical
K840526	AMETHERM	Apr 30, 1984	Substantially Equivalent	Egnell, Inc.
K832418	OHIO TEMPERATURE SIMULATOR	Sep 12, 1983	Substantially Equivalent	Airco/Ohio Medical Products
K822656	C-200 INFANT INCUBATOR	Oct 18, 1982	Substantially Equivalent	Narco Scientific
K821896	C-300 INFANT INCUBATOR	Jul 28, 1982	Substantially Equivalent	Narco Scientific
K813239	OXYGENAIRE NURING INCUBATOR	Jan 28, 1982	Substantially Equivalent	Vickers America Medical Corp.
K813238	NEOCARE BABY-CONTROLLED INCUBATOR	Jan 22, 1982	Substantially Equivalent	Vickers America Medical Corp.
K810792	NEOCARE TEMPERATURE MONITOR	Apr 29, 1981	Substantially Equivalent	Vickers America Medical Corp.
K810067	140 NEOCARE AIR CONTROLLED INCUBATOR	Mar 11, 1981	Substantially Equivalent	Vickers America Medical Corp.
K802640	OHIO GC INCUBATOR	Nov 12, 1980	Substantially Equivalent	Ohio Medical Products
K802639	OHIO IC INCUBATOR	Nov 12, 1980	Substantially Equivalent	Ohio Medical Products
K802126	ISOLETTE INCUBATOR C-100	Sep 26, 1980	Substantially Equivalent	Narco Air-Shields
K801461	THERMA-SHIELD	Jul 28, 1980	Substantially Equivalent	Olympic Medical Corp.
K781876	ISOLETTE INCUBATOR	Dec 07, 1978	Substantially Equivalent	Air-Shields, Inc.
K780472	INFANT INCUBATOR	Apr 19, 1978	Substantially Equivalent	Air-Shields, Inc.