DeviceClearance

Product code ODX— Gastroenterology, Urology

REDSENSE

Classification name
Autonomous Extracorporeal Blood Leak Detector/Alarm
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Total cleared
4
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code ODX under 21 CFR 876.5820, via openFDA

Market context for product code ODX

FDA has cleared 4 devices under product code ODX between 2007 and 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code ODX

Recent clearances under product code ODX

Data sourced from openFDA. This site is unofficial and independent of the FDA.