Data / Medical devices / Incubator, Neonatal Transport
Incubator, Neonatal Transport (FPL): 10 FDA-registered makers in 7 countries
10 establishments in 7 countries are registered with the FDA to make Incubator, Neonatal Transport (product code FPL, Class 2, 21 CFR 880.5410). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 25 510(k) clearances under this code, the latest on July 15, 2022, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FPL
- Device class
- 2
- Regulation
- 880.5410
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Japan | 1 |
| Germany | 1 |
| United Kingdom | 1 |
| China | 1 |
| Taiwan | 1 |
| Mexico | 1 |
Makers of Incubator, Neonatal Transport
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| International Biomedical, Ltd. | Austin, TX, United States | Manufacturer | 8 | July 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Atom Medical Corporation | Sakura-ku, Saitama-shi, Japan | Manufacturer | 2 | May 23, 2013 | 0 | 0 | 0 | api.fda.gov |
| Draeger Medical Systems, Inc. | Telford, PA, United States | Manufacturer | 2 | April 27, 2000 | 0 | 1 | 0 | api.fda.gov |
| LMT Medical Systems GMBH | Lubeck Schleswig-Holstein, Germany | Complaint file establishment, Exporter to the US, Manufacturer | 2 | July 31, 2006 | 0 | 0 | 0 | api.fda.gov |
| Flexicare Medical Ltd. | RHONDDA CYNON TAFF Wales, United Kingdom | Specification developer | 1 | May 23, 2013 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol (Changzhou) Connector Systems Co., Ltd. | Changzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New V-Key Technology Co., Ltd. | New Taipei City, Taipei, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thermometrics Mexico, S.A. de C.V | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Warmilu LLC | Ann Arbor, MI, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 15, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.