510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
ODXClass II

Autonomous Extracorporeal Blood Leak Detector/Alarm

21 CFR 876.5820 / Gastroenterology, Urology
FDA source (opens on fda.gov)

ODX is the FDA product code for Autonomous Extracorporeal Blood Leak Detector/Alarm, a class II device type, regulated under 21 CFR 876.5820. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
ODX
Device name
Autonomous Extracorporeal Blood Leak Detector/Alarm
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.
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code ODX

By decision year
4 clearances under product code ODX with a decision year between 2007 and 2013, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ODX by decision year
YearClearances
20071
20101
20111
20131

Applicants with the most clearances

Product code ODX
Applicants holding the most 510(k) clearances under product code ODX
ApplicantClearances
Redsense Medical AB4

Companies listing this code with FDA

Companies whose registered establishments list this code