Babyleo TN500
Babyleo TN500 provides a controlled warming environment for neonates and infants. It operates as either an enclosed incubator or an open radiant warmer, with conditions including…
Babyleo TN500 provides a controlled warming environment for neonates and infants. It operates as either an enclosed incubator or an open radiant warmer, with conditions including temperature, humidity and oxygen managed for the patient’s microenvironment.
Radiant and convective heat sources coordinate warming, with an optional heated mattress adding conductive warmth. Closing the hood automatically switches the device from radiant warmer operation to incubator operation.
Access and Mobility
Hand ports and opening side panels provide care access. A height adjustable trolley and casters support positioning and movement. An optional battery powers convective heating for limited intrahospital transport in incubator mode, while optional scales can measure patient weight.
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol (Changzhou) Connector Systems Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Drägerwerk AG & Co. KGaA, Germany |
|---|---|
| FDA product code | FMZ |
| Device type | Incubator, Neonatal |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5400 |
| 510(k) | K251619 |
| Record published | 2026-03-23 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2M61100 | In distribution | |
| 2M60000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tarry Probes | Tarry Medical Products, Inc. | 7 |
| Midas Rex MR8 | Medtronic Powered Surgical Solutions | 6 |
| Airlife | AirLife Finland Oy | 6 |
| AirLife | Carefusion Finland 320 Oy | 5 |
| Multi-Link™ | AirLife Finland Oy | 3 |
| Access Medical Probes | Tarry Medical Products, Inc. | 3 |
| Advanced Neonatal Incubator | Advanced Instrumentations, Inc. | 2 |
| Isolette® 8000 plus | Draeger Medical Systems, Inc. | 2 |
| Isolette 8000 Infant Incubator | Draeger Medical Systems, Inc. | 1 |
| Skin Temp Probe, 5mm O.D.(Y) | Atom Medical Corporation | 1 |
| Oxygen Sensor For Dual Incu i, Incu i, V-2200/2100G(2 pcs/set) | Atom Medical Corporation | 1 |
| Caleo | Drägerwerk AG & Co. KGaA | 1 |
Showing 12 of 41. All products under Incubator, Neonatal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251619 | 2026-02-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.