Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)— 510(k) K243840

Name: FDA 510(k) clearance K243840
Creator: U.S. Food and Drug Administration
Published: 2025-03-26

Substantially Equivalent

Bridge TO Life

FDA 510(k) clearance K243840 for Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001), Substantially Equivalent on 2025-03-26. Applicant: Bridge TO Life. Device class: 2.

Clearance details

Applicant: Bridge TO Life
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2024-12-13
Decision date: 2025-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KDN

view all

K261644 — Perfadex Plus2026-07-23
K260456 — VI°Port Liver Preservation System2026-06-01
K254305 — BAROguard Donor Lung Preservation System2026-01-30
K243618 — EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)2025-06-17
K243870 — X°Port Lung Preservation System; X°Port Lung Preservation Solution2025-05-01

More clearances from Bridge TO Life

view all

K243384 — Belzer UW® Cold Storage Solution (BTLBUW-001)2025-03-31

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