Autonomous Extracorporeal Blood Leak Detector/Alarm
The Autonomous Extracorporeal Blood Leak Detector/Alarm (product code ODX) is a gastroenterology/urology device used in hemodialysis settings to detect the presence of blood leaking from extracorporeal connections or needle sites, alerting the user or attending staff via colorimetric, chemical, or light modulation changes caused by exposure to leaking blood. Early detection of blood leaks helps prevent life-threatening blood loss in dialysis patients. This device is FDA Class 2 under regulation 876.5820 in the Gastroenterology, Urology specialty, requiring 510(k) clearance and compliance with general and special controls. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- ODX
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K130554 | REDSENSE ALARM SYSTEM | Nov 22, 2013 | Substantially Equivalent | Redsense Medical AB |
| K103242 | REDSENSE-ALARM UNIT AND SENSOR | Feb 10, 2011 | Substantially Equivalent | Redsense Medical AB |
| K092955 | REDSENSE-HOME USE | May 10, 2010 | Substantially Equivalent | Redsense Medical AB |
| K071013 | REDSENSE | Oct 18, 2007 | Substantially Equivalent | Redsense Medical AB |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.