Data / Medical devices / Fluid Drainage Tray
Fluid Drainage Tray (PXU): 14 FDA-registered makers in 9 countries
14 establishments in 9 countries are registered with the FDA to make Fluid Drainage Tray (product code PXU, Class 1, 21 CFR 878.4200). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PXU
- Device class
- 1
- Regulation
- 878.4200
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 3 |
| Mexico | 1 |
| Kenya | 1 |
| Thailand | 1 |
| Switzerland | 1 |
| Denmark | 1 |
| Poland | 1 |
| Malaysia | 1 |
Makers of Fluid Drainage Tray
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 |
|---|---|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enpro Trading (hong Kong) Limited | Wan Chai Wan Chai Hong Kong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan King Wonder Hi-Tech Co.,ltd. | Foshan Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fullcare (kenya) Medical Sez Limited | Nairobi Nairobi City, Kenya | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jeeli Industrial Company Limited | BangPakong Chachoengsao, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu JianYu Health Medical Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LiNA Medical AG | Root D4 Luzern, Switzerland | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LiNA Medical ApS | Naerum Hovedstaden, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LiNA Medical Polska sp. z o.o | Tarnowo Podgorne Wielkopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Madewell Medical Technology (malaysia) Sdn., Bhd. | Kuala Ketil Kedah, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | Houston, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PFM Medical, Inc | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.