Atlas FDA

FMZ

86 FDA 510(k) clearances · Product code

91 daysmedian time to decision
282 days90th percentile
86clearances measured

FDA profile

Official device name
Incubator, Neonatal
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5400
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 15 · 2022: 27 · 2023: 19 · 2024: 118 · 2025: 254 · 2026: 112
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
Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) (K260326)Datex-Ohmeda, Inc.2026-07-28
Babyleo TN500 (K251619)Drägerwerk AG & Co. KGaA2026-02-13
Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (K251663)Datex-Ohmeda, Inc.2025-10-22
mOm Essential Incubator (ME1) (K243437)Mom Incubators Limited2025-08-14
Giraffe Incubator Carestation CS1 (K213553)Datex Ohmeda, Inc.2022-03-02
Infant Incubator (K190494)Ningbo David Medical Device Co., Ltd.2019-11-25
Babyleo TN500 (K182859)Dragerwerk AG & CO Kgaa2019-02-22
Isolette 8000 Plus (K182977)Draeger Medical Systems, Inc.2018-11-21
Isolette 8000 plus (K172154)Draeger Medical Sytems, Inc.2018-04-19
Babyleo TN500 (K162821)Draegerwerk AG & CO Kgaa2017-06-23
Giraffe OmniBed Carestation CS1 (K152814)Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company2016-03-17
Giraffe Incubator Carestation CS1 (K152809)Ohmeda Medical, A Division of Datex-Ohmeda, Inc.2015-12-31
INFANT INCUBATOR (K132543)Bistos Co., Ltd.2014-07-03
DUAL INCU I (K102226)Atom Medical Corporation2011-01-04
INCU I (K102279)Atom Medical Corporation2010-12-29
NEO-SERVO I (K102710)Atom Medical Corporation2010-12-22
GIRAFFE INCUBATOR (K101778)Ohmeda Medical2010-07-21
GIRAFFE OMNIBED (K101788)Ohmeda Medical2010-07-21
TARRY MEDICAL TEMPERATURE PROBES (K071977)Tarry Medical Products, Inc.2008-05-23
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) (K072512)Datex-Ohmeda, Inc.2007-10-03
MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX (K070291)Medix I.C.S.A.2007-09-21
OHMEDA MEDICAL GIRAFFE OMNIBED (K071175)GE Healthcare2007-07-17
V-2200 INFANT INCUBATOR (K061856)Atom Medical, Inc.2006-09-28
VERSALET 7700 CARE CENTER (K053399)Draeger Medical Infant Care, Inc.2006-08-04
V-2200 INFANT INCUBATOR (K061280)Neoforce Group, Inc.2006-06-27
INFANT INCUBATOR, MODEL CHS-I1000 (K040910)Choong Wae Medical Corp.2004-04-21
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM (K040068)Ohmeda Medical2004-04-16
ISOLETTE INFANT INCUBATOR, MODEL C2000E (K031387)Hill-Rom Manufacturing, Inc.2003-08-01
V-2100G ADVANCED INFANT INCUBATOR (K021809)Atom Medical Corp2002-07-18
OHMEDA MEDICAL GIRAFFE INCUBATOR (K020547)Ohmeda Medical2002-05-09
OHMEDA MEDICAL GIRAFFE OMNIBED (K020543)Ohmeda Medical2002-05-09
OHMEDA MEDICAL GIRAFFE INCUBATOR (K010222)Ohmeda Medical2001-03-21
CALEO (K003067)Drager Medizintechnik GmbH2000-12-13
ISOLETTE INFANT INCUBATOR, MODEL C2HS (K001242)Hill-Rom Air-Shields2000-07-13
VERSALET 7700 CARE CENTER, MODEL # 7700 (K993051)Hill-Rom Air-Shields2000-02-03
OHMEDA MEDICAL OMNIBED (K993407)Ohmeda Medical2000-01-05
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM (K993712)Ohmeda Medical1999-11-09
BABYTHERM 8000 LDR (K980886)Draeger Medical, Inc.1998-05-29
OHMEDA-OHIO CARE PLUS INCUBATOR (K974349)Ohmeda Medical1998-02-12
DRAGER INCUBATOR 8000 IC (K954204)Drager, Inc.1997-04-25
OHMEDA-OHIO CAE PLUS INCUBATOR (K962806)Ohmeda Medical1996-09-20
ISOLETTE INFANT INCUBATOR (K960980)Air-Shields, Inc.1996-07-30
OHIO CARE PLUS INCUBATOR (K943360)Ohmeda Medical1994-09-29
C450/C400 INFANT INCUBATORS (K940975)Air-Shields, Inc.1994-06-23
K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE (K924324)K-1 Medical Products, Inc.1993-11-12
BOWRON (K922618)G.L. Bowron & Co. , Ltd.1993-08-19
MEDIX PC-305 NEONATAL INCUBATOR (K920049)Medix I.C.S.A.1993-05-21
DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER (K924297)Air-Shields Vickers, Inc.1993-03-18
ISOLETTE INCUBATOR HUMIDITY METER (K924170)Air-Shields, Inc.1993-02-05
TYPE INTERFACE 9271/1 INCUBATOR/WARMER (K912000)S & W Medico Teknik1992-09-21
FIRST TOUCH/VILEDON NON-WOVEN FILTER (K915752)First Touch Disposables, Inc.1992-09-17
MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR (K914864)Air-Shields, Inc.1992-03-13
OHIO CARE PLUS INCUBATOR (K914487)Ohmeda Medical1991-12-18
INCUBATOR 8000 SC (K914134)National Draeger, Inc.1991-11-22
INCUBATOR 8000 IC (K913394)Dragerwerk AG1991-11-22
MODEL C386 ISOLETTE(R) INFANT INCUBATOR (K913291)Air-Shields, Inc.1991-11-13
SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM (K912909)Air-Shields Vickers, Inc.1991-11-05
C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM (K912910)Air-Shields Vickers, Inc.1991-10-30
OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION (K913154)Ohmeda Medical1991-09-13
MP4, MP4SI, IT4 INCUBATORS (K901157)Mediprema1991-03-27
MODEL C286 ISOLETTE INFANT INCUBATOR (K903378)Air-Shields Vickers, Inc.1990-10-15
INCUBATOR 8000 (K900752)Dragerwerk AG1990-08-02
OHMEDA - OHIO(R) CARE PLUS INCUBATOR (K901585)Ohmeda Medical1990-06-22
MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR (K900735)Preemicare Corp.1990-05-02
NEONATAL INCUBATOR (ACCESSORY) (K895782)Air-Shields Vickers, Inc.1989-12-07
K-1 INFANT TRANSPORT SYSTEM (K895550)K-1 Medical Products, Inc.1989-12-07
ADEL - MODEL 986 INFANT WARMER (K890476)Adel Medical , Ltd.1989-06-16
PREEMICARE MODEL D1-X1, SERIES 3000 (K881476)Preemicare Corp.1988-12-08
C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR (K884086)Air-Shields Vickers, Inc.1988-11-14
AMEDA AMECARE(R) NEONATAL INCUBATOR (K870222)Hollister, Inc.1987-06-10
AMEDA AMELETTE(R) NEONATAL INCUBATOR (K870223)Hollister, Inc.1987-06-10
OHIO(R) CARE PLUS INCUBATOR (K871399)Ohmeda Medical1987-06-05
AMETHERM (K840526)Egnell, Inc.1984-04-30
OHIO TEMPERATURE SIMULATOR (K832418)Airco/Ohio Medical Products1983-09-12
C-200 INFANT INCUBATOR (K822656)Narco Scientific1982-10-18
C-300 INFANT INCUBATOR (K821896)Narco Scientific1982-07-28
OXYGENAIRE NURING INCUBATOR (K813239)Vickers America Medical Corp.1982-01-28
NEOCARE BABY-CONTROLLED INCUBATOR (K813238)Vickers America Medical Corp.1982-01-22
NEOCARE TEMPERATURE MONITOR (K810792)Vickers America Medical Corp.1981-04-29
140 NEOCARE AIR CONTROLLED INCUBATOR (K810067)Vickers America Medical Corp.1981-03-11
OHIO IC INCUBATOR (K802639)Ohio Medical Products1980-11-12
OHIO GC INCUBATOR (K802640)Ohio Medical Products1980-11-12
ISOLETTE INCUBATOR C-100 (K802126)Narco Air-Shields1980-09-26
THERMA-SHIELD (K801461)Olympic Medical Corp.1980-07-28
ISOLETTE INCUBATOR (K781876)Air-Shields, Inc.1978-12-07
INFANT INCUBATOR (K780472)Air-Shields, Inc.1978-04-19

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