Data / Medical devices / Autonomous Extracorporeal Blood Leak Detector/Alarm
Autonomous Extracorporeal Blood Leak Detector/Alarm (ODX): 5 FDA-registered makers in 4 countries
5 establishments in 4 countries are registered with the FDA to make Autonomous Extracorporeal Blood Leak Detector/Alarm (product code ODX, Class 2, 21 CFR 876.5820). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on November 22, 2013, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- ODX
- Device class
- 2
- Regulation
- 876.5820
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| Mexico | 2 |
| Sweden | 1 |
| United States | 1 |
| China | 1 |
Makers of Autonomous Extracorporeal Blood Leak Detector/Alarm
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 |
|---|---|---|---|---|---|---|---|---|
| Redsense Medical AB | Halmstad Halland, Sweden | Manufacturer, Specification developer | 4 | November 22, 2013 | 0 | 0 | 0 | api.fda.gov |
| Erika De Reynosa, S.A. De C.V. | CD, REYNOSA Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erika De Reynosa, S.A. De C.V. | CD, REYNOSA Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Medical Care Renal Therapies Group, LLC | Waltham, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Linxens Healthcare (Tianjin) Co., Ltd | JinNan District Tianjin, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 22, 2013. 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.