Autonomous Extracorporeal Blood Leak Detector/Alarm

ODX · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5820

Classification

FDA Product Code: ODX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5820
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 8

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown