FMZ · Incubator, Neonatal
General Hospital · 21 CFR 880.5400 · Class 2
Overview
| Product Code | FMZ |
|---|---|
| Device Name | Incubator, Neonatal |
| Regulation | 21 CFR 880.5400 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 85)
Showing 20 most recent of 85 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251619 | Babyleo TN500 | Drägerwerk AG & Co. KGaA | Feb 13, 2026 | SESE |
| K251663 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | Oct 22, 2025 | SESE |
| K243437 | mOm Essential Incubator (ME1) | Mom Incubators Limited | Aug 14, 2025 | SESE |
| K213553 | Giraffe Incubator Carestation CS1 | Datex Ohmeda, Inc. | Mar 2, 2022 | SESE |
| K190494 | Infant Incubator | Ningbo David Medical Device Co., Ltd. | Nov 25, 2019 | SESE |
| K182859 | Babyleo TN500 | Dragerwerk AG & CO Kgaa | Feb 22, 2019 | SESE |
| K182977 | Isolette 8000 Plus | Draeger Medical Systems, Inc. | Nov 21, 2018 | SESE |
| K172154 | Isolette 8000 plus | Draeger Medical Sytems, Inc. | Apr 19, 2018 | SESE |
| K162821 | Babyleo TN500 | Draegerwerk AG & CO Kgaa | Jun 23, 2017 | SESE |
| K152814 | Giraffe OmniBed Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | Mar 17, 2016 | SESE |
| K152809 | Giraffe Incubator Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | Dec 31, 2015 | SESE |
| K132543 | INFANT INCUBATOR | Bistos Co., Ltd. | Jul 3, 2014 | SESE |
| K102226 | DUAL INCU I | Atom Medical Corporation | Jan 4, 2011 | SESE |
| K102279 | INCU I | Atom Medical Corporation | Dec 29, 2010 | SESE |
| K102710 | NEO-SERVO I | Atom Medical Corporation | Dec 22, 2010 | SESE |
| K101788 | GIRAFFE OMNIBED | Ohmeda Medical | Jul 21, 2010 | SESE |
| K101778 | GIRAFFE INCUBATOR | Ohmeda Medical | Jul 21, 2010 | SESE |
| K071977 | TARRY MEDICAL TEMPERATURE PROBES | Tarry Medical Products, Inc. | May 23, 2008 | SESE |
| K072512 | MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | Datex-Ohmeda, Inc. | Oct 3, 2007 | SESE |
| K070291 | MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX | Medix I.C.S.A. | Sep 21, 2007 | SESE |
Top Applicants
- Ohmeda Medical — 15 clearances
- Air-Shields, Inc. — 7 clearances
- Air-Shields Vickers, Inc. — 6 clearances
- Vickers America Medical Corp. — 4 clearances
- Atom Medical Corporation — 3 clearances
