FMZ · Class II · 21 CFR 880.5400

FDA Product Code FMZ: Incubator, Neonatal

Leading manufacturers include Ohmeda Medical, Datex-Ohmeda, Inc. and Ohio Medical Products.

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 Jul 21, 2010
GIRAFFE INCUBATOR
K101778
Ohmeda Medical
General Hospital · 26d
Cleared Jul 21, 2010
GIRAFFE OMNIBED
K101788
Ohmeda Medical
General Hospital · 26d
Cleared Oct 03, 2007
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
K072512
Datex-Ohmeda, Inc.
General Hospital · 27d
Cleared Jul 17, 2007
OHMEDA MEDICAL GIRAFFE OMNIBED
K071175
Ge Healthcare
General Hospital · 81d
Cleared Apr 16, 2004
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
K040068
Ohmeda Medical
General Hospital · 93d
Cleared May 09, 2002
OHMEDA MEDICAL GIRAFFE OMNIBED
K020543
Ohmeda Medical
General Hospital · 79d
Cleared May 09, 2002
OHMEDA MEDICAL GIRAFFE INCUBATOR
K020547
Ohmeda Medical
General Hospital · 79d
Cleared Mar 21, 2001
OHMEDA MEDICAL GIRAFFE INCUBATOR
K010222
Ohmeda Medical
General Hospital · 56d
Cleared Jan 05, 2000
OHMEDA MEDICAL OMNIBED
K993407
Ohmeda Medical
General Hospital · 89d
Cleared Nov 09, 1999
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
K993712
Ohmeda Medical
General Hospital · 6d
Cleared May 29, 1998
BABYTHERM 8000 LDR
K980886
Draeger Medical, Inc.
General Hospital · 81d
Cleared Feb 12, 1998
OHMEDA-OHIO CARE PLUS INCUBATOR
K974349
Ohmeda Medical
General Hospital · 85d
Cleared Sep 20, 1996
OHMEDA-OHIO CAE PLUS INCUBATOR
K962806
Ohmeda Medical
General Hospital · 64d
Cleared Sep 29, 1994
OHIO CARE PLUS INCUBATOR
K943360
Ohmeda Medical
General Hospital · 79d
Cleared Sep 21, 1992
TYPE INTERFACE 9271/1 INCUBATOR/WARMER
K912000
S & W Medico Teknik
General Hospital · 516d

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 →