ODX
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Autonomous Extracorporeal Blood Leak Detector/Alarm
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff. The device detects colormetric, chemical, or light modulation caused by exposure to leaking blood.
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| Record | Firm | Date |
|---|---|---|
| REDSENSE ALARM SYSTEM (K130554) | Redsense Medical AB | 2013-11-22 |
| REDSENSE-ALARM UNIT AND SENSOR (K103242) | Redsense Medical AB | 2011-02-10 |
| REDSENSE-HOME USE (K092955) | Redsense Medical AB | 2010-05-10 |
| REDSENSE (K071013) | Redsense Medical AB | 2007-10-18 |
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Every clearance here is in the API, with alerts when new ones post.