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/productcode/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](/device/K251619.md) | Babyleo TN500 | Drägerwerk AG & Co. KGaA | Feb 13, 2026 | SESE |
| [K251663](/device/K251663.md) | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | Oct 22, 2025 | SESE |
| [K243437](/device/K243437.md) | mOm Essential Incubator (ME1) | Mom Incubators Limited | Aug 14, 2025 | SESE |
| [K213553](/device/K213553.md) | Giraffe Incubator Carestation CS1 | Datex Ohmeda, Inc. | Mar 2, 2022 | SESE |
| [K190494](/device/K190494.md) | Infant Incubator | Ningbo David Medical Device Co., Ltd. | Nov 25, 2019 | SESE |
| [K182859](/device/K182859.md) | Babyleo TN500 | Dragerwerk AG & CO Kgaa | Feb 22, 2019 | SESE |
| [K182977](/device/K182977.md) | Isolette 8000 Plus | Draeger Medical Systems, Inc. | Nov 21, 2018 | SESE |
| [K172154](/device/K172154.md) | Isolette 8000 plus | Draeger Medical Sytems, Inc. | Apr 19, 2018 | SESE |
| [K162821](/device/K162821.md) | Babyleo TN500 | Draegerwerk AG & CO Kgaa | Jun 23, 2017 | SESE |
| [K152814](/device/K152814.md) | Giraffe OmniBed Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company | Mar 17, 2016 | SESE |
| [K152809](/device/K152809.md) | Giraffe Incubator Carestation CS1 | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | Dec 31, 2015 | SESE |
| [K132543](/device/K132543.md) | INFANT INCUBATOR | Bistos Co., Ltd. | Jul 3, 2014 | SESE |
| [K102226](/device/K102226.md) | DUAL INCU I | Atom Medical Corporation | Jan 4, 2011 | SESE |
| [K102279](/device/K102279.md) | INCU I | Atom Medical Corporation | Dec 29, 2010 | SESE |
| [K102710](/device/K102710.md) | NEO-SERVO I | Atom Medical Corporation | Dec 22, 2010 | SESE |
| [K101788](/device/K101788.md) | GIRAFFE OMNIBED | Ohmeda Medical | Jul 21, 2010 | SESE |
| [K101778](/device/K101778.md) | GIRAFFE INCUBATOR | Ohmeda Medical | Jul 21, 2010 | SESE |
| [K071977](/device/K071977.md) | TARRY MEDICAL TEMPERATURE PROBES | Tarry Medical Products, Inc. | May 23, 2008 | SESE |
| [K072512](/device/K072512.md) | MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) | Datex-Ohmeda, Inc. | Oct 3, 2007 | SESE |
| [K070291](/device/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/productcode/FMZ](https://fda.innolitics.com/productcode/FMZ)

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