Product code FMZ
- Device name
- Incubator, Neonatal
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5400
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251619 | Babyleo TN500 | Drägerwerk AG & Co. KGaA | 2026-02-13 |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | 2025-10-22 |
| K243437 | mOm Essential Incubator (ME1) | Mom Incubators Limited | 2025-08-14 |
| K213553 | Giraffe Incubator Carestation CS1 | Datex Ohmeda, Inc. | 2022-03-02 |
| K190494 | Infant Incubator | Ningbo David Medical Device Co., Ltd. | 2019-11-25 |
| K182859 | Babyleo TN500 | Dragerwerk AG & CO Kgaa | 2019-02-22 |
| K182977 | Isolette 8000 Plus | Draeger Medical Systems, Inc. | 2018-11-21 |
| K172154 | Isolette 8000 plus | Draeger Medical Sytems, Inc. | 2018-04-19 |
| K162821 | Babyleo TN500 | Draegerwerk AG & CO Kgaa | 2017-06-23 |
| K152814 | Giraffe OmniBed Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | 2016-03-17 |
| K152809 | Giraffe Incubator Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2015-12-31 |
| K132543 | INFANT INCUBATOR | Bistos Co., Ltd. | 2014-07-03 |
| K102226 | DUAL INCU I | Atom Medical Corporation | 2011-01-04 |
| K102279 | INCU I | Atom Medical Corporation | 2010-12-29 |
| K102710 | NEO-SERVO I | Atom Medical Corporation | 2010-12-22 |
| K101778 | GIRAFFE INCUBATOR | Ohmeda Medical | 2010-07-21 |
| K101788 | GIRAFFE OMNIBED | Ohmeda Medical | 2010-07-21 |
| K071977 | TARRY MEDICAL TEMPERATURE PROBES | Tarry Medical Products, Inc. | 2008-05-23 |
| K072512 | MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | Datex-Ohmeda, Inc. | 2007-10-03 |
| K070291 | MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX | Medix I.C.S.A. | 2007-09-21 |
| K071175 | OHMEDA MEDICAL GIRAFFE OMNIBED | GE Healthcare | 2007-07-17 |
| K061856 | V-2200 INFANT INCUBATOR | Atom Medical, Inc. | 2006-09-28 |
| K053399 | VERSALET 7700 CARE CENTER | Draeger Medical Infant Care, Inc. | 2006-08-04 |
| K061280 | V-2200 INFANT INCUBATOR | Neoforce Group, Inc. | 2006-06-27 |
| K040910 | INFANT INCUBATOR, MODEL CHS-I1000 | Choong Wae Medical Corp. | 2004-04-21 |
| K040068 | BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM | Ohmeda Medical | 2004-04-16 |
| K031387 | ISOLETTE INFANT INCUBATOR, MODEL C2000E | Hill-Rom Manufacturing, Inc. | 2003-08-01 |
| K021809 | V-2100G ADVANCED INFANT INCUBATOR | Atom Medical Corp | 2002-07-18 |
| K020543 | OHMEDA MEDICAL GIRAFFE OMNIBED | Ohmeda Medical | 2002-05-09 |
| K020547 | OHMEDA MEDICAL GIRAFFE INCUBATOR | Ohmeda Medical | 2002-05-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04048675641308 | Babyleo TN500 | Drägerwerk AG & Co. KGaA | 2026-03-23 |
| 10889483577387 | AirLife™ | AirLife Finland Oy | 2025-03-26 |
| 20889483577377 | AirLife™ | AirLife Finland Oy | 2025-03-26 |
| 10889483577363 | AirLife™ | AirLife Finland Oy | 2025-03-26 |
| 10889483577370 | AirLife™ | AirLife Finland Oy | 2025-03-26 |
| 20889483577360 | AirLife™ | AirLife Finland Oy | 2025-03-26 |
| B510A31860 | ADVANCED NEONATAL INCUBATOR | ADVANCED INSTRUMENTATIONS, INC. | 2025-02-07 |
| 10190752179608 | Airlife | AirLife Finland Oy | 2021-02-26 |
| 10190752179615 | Airlife | AirLife Finland Oy | 2021-02-26 |
| 10190752106147 | Multi-Link™ | AirLife Finland Oy | 2021-01-13 |
| 10190752106130 | Multi-Link™ | AirLife Finland Oy | 2021-01-13 |
| 04048675020530 | Isolette 8000 plus | DRAEGER MEDICAL SYSTEMS, INC. | 2018-12-03 |
| 00854758006209 | Access Medical Probes | TARRY MEDICAL PRODUCTS, INC. | 2018-09-13 |
| 00854758006193 | Access Medical Probes | TARRY MEDICAL PRODUCTS, INC. | 2018-09-13 |
| 00854758006179 | Access Medical Probes | TARRY MEDICAL PRODUCTS, INC. | 2018-09-13 |
| 10885403253690 | AirLife | Carefusion Finland 320 Oy | 2016-10-17 |
| 10885403253683 | AirLife | Carefusion Finland 320 Oy | 2016-10-17 |
| 00854758006063 | Tarry Probes | TARRY MEDICAL PRODUCTS, INC. | 2016-09-20 |
| 00854758006087 | Tarry Probes | TARRY MEDICAL PRODUCTS, INC. | 2016-09-20 |
| 00854758006117 | Tarry Probes | TARRY MEDICAL PRODUCTS, INC. | 2016-09-20 |
| 00854758006049 | Tarry Probes | TARRY MEDICAL PRODUCTS, INC. | 2016-09-20 |
| 00854758006032 | Tarry Probes | TARRY MEDICAL PRODUCTS, INC. | 2016-09-20 |
| 00854758006001 | Tarry Probes | TARRY MEDICAL PRODUCTS, INC. | 2016-09-20 |
| 00854758006025 | Tarry Probes | TARRY MEDICAL PRODUCTS, INC. | 2016-09-20 |
| 00854758006018 | Tarry Probes | TARRY MEDICAL PRODUCTS, INC. | 2016-09-20 |
| 70885403252923 | AirLife | Carefusion Finland 320 Oy | 2016-09-14 |
| 70885403252916 | AirLife | Carefusion Finland 320 Oy | 2016-09-14 |
| 00887529000137 | N/A | Bistos Co., Ltd. | 2016-06-03 |
| 04048675001065 | OxyTrace Incu | Drägerwerk AG & Co. KGaA | 2015-10-24 |
| 04048675017165 | Caleo | Drägerwerk AG & Co. KGaA | 2015-10-24 |