FMZ — Incubator, Neonatal Class II
FDA product code FMZ covers "Incubator, Neonatal", a Class II medical device regulated under 21 CFR 880.5400. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FMZ
- Device Class
- Class II
- Regulation Number
- 880.5400
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251619 | drägerwerk ag and co. kgaa | Babyleo TN500 | February 13, 2026 |
| K251663 | datex-ohmeda | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | October 22, 2025 |
| K243437 | mom incubators limited | mOm Essential Incubator (ME1) | August 14, 2025 |
| K213553 | datex ohmeda | Giraffe Incubator Carestation CS1 | March 2, 2022 |
| K190494 | ningbo david medical device co | Infant Incubator | November 25, 2019 |
| K182859 | dragerwerk ag and co kgaa | Babyleo TN500 | February 22, 2019 |
| K182977 | draeger medical systems | Isolette 8000 Plus | November 21, 2018 |
| K172154 | draeger medical sytems | Isolette 8000 plus | April 19, 2018 |
| K162821 | draegerwerk ag and co kgaa | Babyleo TN500 | June 23, 2017 |
| K152814 | ohmeda medical, a division of datex-ohmeda,inc. a ge | Giraffe OmniBed Carestation CS1 | March 17, 2016 |
| K152809 | ohmeda medical, a division of datex-ohmeda | Giraffe Incubator Carestation CS1 | December 31, 2015 |
| K132543 | bistos co | INFANT INCUBATOR | July 3, 2014 |
| K102226 | atom medical corporation | DUAL INCU I | January 4, 2011 |
| K102279 | atom medical corporation | INCU I | December 29, 2010 |
| K102710 | atom medical corporation | NEO-SERVO I | December 22, 2010 |
| K101788 | ohmeda medical | GIRAFFE OMNIBED | July 21, 2010 |
| K101778 | ohmeda medical | GIRAFFE INCUBATOR | July 21, 2010 |
| K071977 | tarry medical products | TARRY MEDICAL TEMPERATURE PROBES | May 23, 2008 |
| K072512 | datex-ohmeda | MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPT | October 3, 2007 |
| K070291 | medix i.c | MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX | September 21, 2007 |