Home / 510(k) Clearances / K192869

510(k) K192869

SherpaPak Lung Preservation System , SherpaPak Liver Transport System by Pragonix Technologies — Product Code KDN

K192869 is an FDA 510(k) premarket notification submitted by Pragonix Technologies for the device "SherpaPak Lung Preservation System , SherpaPak Liver Transport System". The FDA issued a decision of Substantially Equivalent (kit) on January 16, 2020. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
January 16, 2020
Date Received
October 7, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Perfusion, Kidney
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
Submission Type

Other clearances for product code KDN

  • K261644 — Perfadex Plus (July 23, 2026)
  • K260456 — VI°Port™ Liver Preservation System (June 1, 2026)
  • K254305 — BAROguard Donor Lung Preservation System (January 30, 2026)
  • K243618 — EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) (June 17, 2025)
  • K243870 — X°Port Lung Preservation System; X°Port Lung Preservation Solution (May 1, 2025)
  • K243998 — DCX Disposable Cassette (DCX) (April 25, 2025)
  • K243384 — Belzer UW® Cold Storage Solution (BTLBUW-001) (March 31, 2025)
  • K243840 — Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (March 26, 2025)
  • K240650 — LungProtect (November 26, 2024)
  • K234060 — KIDNEYvault Portable Renal Perfusion System (October 23, 2024)

FDA data resources