Product code FMZ— General Hospital
Babyleo TN500
- Classification name
- Incubator, Neonatal
- Device class
- Class 2
- Regulation
- 21 CFR 880.5400
- Advisory panel
- General Hospital
- Total cleared
- 86
- First cleared
- Most recent
Market context for product code FMZ
FDA has cleared devices under product code FMZ between 1978 and 2026, filed by 45 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2022
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2011
- 2010
- 2008
- 2007
- 2006
- 2004
Top applicants under product code FMZ
Adverse events under product code FMZ
product code FMZ- Death
- 2
- Malfunction
- 457
- Other
- 1
- Total
- 460
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FMZ
- K260326 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
- K251619 — Babyleo TN500
- K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
- K243437 — mOm Essential Incubator (ME1)
- K213553 — Giraffe Incubator Carestation CS1
- K190494 — Infant Incubator
- K182859 — Babyleo TN500
- K182977 — Isolette 8000 Plus
- K172154 — Isolette 8000 plus
- K162821 — Babyleo TN500
- K152814 — Giraffe OmniBed Carestation CS1
- K152809 — Giraffe Incubator Carestation CS1
- K132543 — INFANT INCUBATOR
- K102226 — DUAL INCU I
- K102279 — INCU I
- K102710 — NEO-SERVO I
- K101778 — GIRAFFE INCUBATOR
- K101788 — GIRAFFE OMNIBED
- K071977 — TARRY MEDICAL TEMPERATURE PROBES
- K072512 — MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
- K070291 — MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
- K071175 — OHMEDA MEDICAL GIRAFFE OMNIBED
- K061856 — V-2200 INFANT INCUBATOR
- K053399 — VERSALET 7700 CARE CENTER
- K061280 — V-2200 INFANT INCUBATOR
- K040910 — INFANT INCUBATOR, MODEL CHS-I1000
- K040068 — BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
- K031387 — ISOLETTE INFANT INCUBATOR, MODEL C2000E
- K021809 — V-2100G ADVANCED INFANT INCUBATOR
- K020543 — OHMEDA MEDICAL GIRAFFE OMNIBED
- K020547 — OHMEDA MEDICAL GIRAFFE INCUBATOR
- K010222 — OHMEDA MEDICAL GIRAFFE INCUBATOR
- K003067 — CALEO
- K001242 — ISOLETTE INFANT INCUBATOR, MODEL C2HS
- K993051 — VERSALET 7700 CARE CENTER, MODEL # 7700
- K993407 — OHMEDA MEDICAL OMNIBED
- K993712 — BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
- K980886 — BABYTHERM 8000 LDR
- K974349 — OHMEDA-OHIO CARE PLUS INCUBATOR
- K954204 — DRAGER INCUBATOR 8000 IC
- K962806 — OHMEDA-OHIO CAE PLUS INCUBATOR
- K960980 — ISOLETTE INFANT INCUBATOR
- K943360 — OHIO CARE PLUS INCUBATOR
- K940975 — C450/C400 INFANT INCUBATORS
- K924324 — K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE
- K922618 — BOWRON
- K920049 — MEDIX PC-305 NEONATAL INCUBATOR
- K924297 — DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER
- K924170 — ISOLETTE INCUBATOR HUMIDITY METER
- K912000 — TYPE INTERFACE 9271/1 INCUBATOR/WARMER
- K915752 — FIRST TOUCH/VILEDON NON-WOVEN FILTER
- K914864 — MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR
- K914487 — OHIO CARE PLUS INCUBATOR
- K913394 — INCUBATOR 8000 IC
- K914134 — INCUBATOR 8000 SC
- K913291 — MODEL C386 ISOLETTE(R) INFANT INCUBATOR
- K912909 — SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM
- K912910 — C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM
- K913154 — OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION
- K901157 — MP4, MP4SI, IT4 INCUBATORS
- K903378 — MODEL C286 ISOLETTE INFANT INCUBATOR
- K900752 — INCUBATOR 8000
- K901585 — OHMEDA - OHIO(R) CARE PLUS INCUBATOR
- K900735 — MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR
- K895550 — K-1 INFANT TRANSPORT SYSTEM
- K895782 — NEONATAL INCUBATOR (ACCESSORY)
- K890476 — ADEL - MODEL 986 INFANT WARMER
- K881476 — PREEMICARE MODEL D1-X1, SERIES 3000
- K884086 — C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR
- K870222 — AMEDA AMECARE(R) NEONATAL INCUBATOR
- K870223 — AMEDA AMELETTE(R) NEONATAL INCUBATOR
- K871399 — OHIO(R) CARE PLUS INCUBATOR
- K840526 — AMETHERM
- K832418 — OHIO TEMPERATURE SIMULATOR
- K822656 — C-200 INFANT INCUBATOR
- K821896 — C-300 INFANT INCUBATOR
- K813239 — OXYGENAIRE NURING INCUBATOR
- K813238 — NEOCARE BABY-CONTROLLED INCUBATOR
- K810792 — NEOCARE TEMPERATURE MONITOR
- K810067 — 140 NEOCARE AIR CONTROLLED INCUBATOR
- K802639 — OHIO IC INCUBATOR
- K802640 — OHIO GC INCUBATOR
- K802126 — ISOLETTE INCUBATOR C-100
- K801461 — THERMA-SHIELD
- K781876 — ISOLETTE INCUBATOR
- K780472 — INFANT INCUBATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.