ODX

Autonomous Extracorporeal Blood Leak Detector/Alarm

Product code

ODX

Device name

Autonomous Extracorporeal Blood Leak Detector/Alarm

Device class

Class 2

21 CFR

21 CFR 876.5820

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).