Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5400](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5400) → FMZ — Incubator, Neonatal # FMZ · Incubator, Neonatal _General Hospital · 21 CFR 880.5400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ ## Overview - **Product Code:** FMZ - **Device Name:** Incubator, Neonatal - **Regulation:** [21 CFR 880.5400](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5400) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K251619.md) | Babyleo TN500 | Drägerwerk AG & Co. KGaA | Feb 13, 2026 | SESE | | [K251663](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K251663.md) | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | Oct 22, 2025 | SESE | | [K243437](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K243437.md) | mOm Essential Incubator (ME1) | Mom Incubators Limited | Aug 14, 2025 | SESE | | [K213553](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K213553.md) | Giraffe Incubator Carestation CS1 | Datex Ohmeda, Inc. | Mar 2, 2022 | SESE | | [K190494](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K190494.md) | Infant Incubator | Ningbo David Medical Device Co., Ltd. | Nov 25, 2019 | SESE | | [K182859](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K182859.md) | Babyleo TN500 | Dragerwerk AG & CO Kgaa | Feb 22, 2019 | SESE | | [K182977](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K182977.md) | Isolette 8000 Plus | Draeger Medical Systems, Inc. | Nov 21, 2018 | SESE | | [K172154](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K172154.md) | Isolette 8000 plus | Draeger Medical Sytems, Inc. | Apr 19, 2018 | SESE | | [K162821](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K162821.md) | Babyleo TN500 | Draegerwerk AG & CO Kgaa | Jun 23, 2017 | SESE | | [K152814](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K152814.md) | Giraffe OmniBed Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | Mar 17, 2016 | SESE | | [K152809](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K152809.md) | Giraffe Incubator Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | Dec 31, 2015 | SESE | | [K132543](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K132543.md) | INFANT INCUBATOR | Bistos Co., Ltd. | Jul 3, 2014 | SESE | | [K102226](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K102226.md) | DUAL INCU I | Atom Medical Corporation | Jan 4, 2011 | SESE | | [K102279](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K102279.md) | INCU I | Atom Medical Corporation | Dec 29, 2010 | SESE | | [K102710](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K102710.md) | NEO-SERVO I | Atom Medical Corporation | Dec 22, 2010 | SESE | | [K101788](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K101788.md) | GIRAFFE OMNIBED | Ohmeda Medical | Jul 21, 2010 | SESE | | [K101778](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K101778.md) | GIRAFFE INCUBATOR | Ohmeda Medical | Jul 21, 2010 | SESE | | [K071977](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K071977.md) | TARRY MEDICAL TEMPERATURE PROBES | Tarry Medical Products, Inc. | May 23, 2008 | SESE | | [K072512](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K072512.md) | MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | Datex-Ohmeda, Inc. | Oct 3, 2007 | SESE | | [K070291](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ/K070291.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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