FMZ · Class II · 21 CFR 880.5400

FDA Product Code FMZ: Incubator, Neonatal

Leading manufacturers include Ohmeda Medical, Air-Shields, Inc. and Air-Shields Vickers, Inc..

86
Total
86
Cleared
136d
Avg days
1978
Since
Growing category - 4 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 217d recently vs 132d historically

FDA 510(k) Cleared Incubator, Neonatal Devices (Product Code FMZ)

86 devices
1–24 of 86
Cleared Jul 28, 2026
Giraffe™ OmniBed™ Carestation (CS1)
K260326
Datex-Ohmeda, Inc.
General Hospital · 179d
Cleared Feb 13, 2026
Babyleo TN500
K251619
Dr?gerwerk AG & Co KGaA
General Hospital · 262d
Cleared Oct 22, 2025
Giraffe OmniBed Carestation (CS1)
K251663
Datex-Ohmeda, Inc.
General Hospital · 145d
Cleared Aug 14, 2025
mOm Essential Incubator (ME1)
K243437
Mom Incubators Limited
General Hospital · 282d
Cleared Mar 02, 2022
Giraffe Incubator Carestation CS1
K213553
Datex-Ohmeda, Inc.
General Hospital · 114d
Cleared Nov 25, 2019
Infant Incubator
K190494
Ningbo David Medical Device Co., Ltd.
General Hospital · 270d
Cleared Feb 22, 2019
Babyleo TN500
K182859
Dragerwerk AG & CO Kgaa
General Hospital · 134d
Cleared Nov 21, 2018
Isolette 8000 Plus
K182977
Draeger Medical Systems, Inc.
General Hospital · 26d
Cleared Apr 19, 2018
Isolette 8000 plus
K172154
Draeger Medical Sytems, Inc.
General Hospital · 276d
Cleared Jun 23, 2017
Babyleo TN500
K162821
Draegerwerk AG & CO Kgaa
General Hospital · 259d
Cleared Mar 17, 2016
Giraffe OmniBed Carestation CS1
K152814
Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company
General Hospital · 171d
Cleared Dec 31, 2015
Giraffe Incubator Carestation CS1
K152809
Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
General Hospital · 94d
Cleared Jul 03, 2014
INFANT INCUBATOR
K132543
Bistos Co., Ltd.
General Hospital · 324d
Cleared Jan 04, 2011
DUAL INCU I
K102226
Atom Medical Corporation
General Hospital · 148d
Cleared Dec 29, 2010
INCU I
K102279
Atom Medical Corporation
General Hospital · 140d
Cleared Dec 22, 2010
NEO-SERVO I
K102710
Atom Medical Corporation
General Hospital · 93d
Cleared Jul 21, 2010
GIRAFFE INCUBATOR
K101778
Ohmeda Medical
General Hospital · 26d
Cleared Jul 21, 2010
GIRAFFE OMNIBED
K101788
Ohmeda Medical
General Hospital · 26d
Cleared May 23, 2008
TARRY MEDICAL TEMPERATURE PROBES
K071977
Tarry Medical Products, Inc.
General Hospital · 311d
Cleared Oct 03, 2007
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
K072512
Datex-Ohmeda, Inc.
General Hospital · 27d
Cleared Sep 21, 2007
MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
K070291
Medix I.C.S.A.
General Hospital · 234d
Cleared Jul 17, 2007
OHMEDA MEDICAL GIRAFFE OMNIBED
K071175
Ge Healthcare
General Hospital · 81d
Cleared Sep 28, 2006
V-2200 INFANT INCUBATOR
K061856
Atom Medical, Inc.
General Hospital · 90d
Cleared Aug 04, 2006
VERSALET 7700 CARE CENTER
K053399
Draeger Medical Infant Care, Inc.
General Hospital · 241d

About Product Code FMZ - Regulatory Context

510(k) Submission Activity

86 total 510(k) submissions under product code FMZ since 1978, with 86 receiving FDA clearance (average review time: 136 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - FMZ Product Code

Recent submissions under FMZ have taken an average of 217 days to reach a decision - up from 132 days historically. Manufacturers should account for longer review timelines in current project planning.

FMZ devices are reviewed by the General Hospital panel. Browse all General Hospital devices →