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510(k) K240650

LungProtect by Traferox Technologies, Inc. — Product Code KDN

K240650 is an FDA 510(k) premarket notification submitted by Traferox Technologies, Inc. for the device "LungProtect". The FDA issued a decision of Substantially Equivalent on November 26, 2024. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. Traferox Technologies, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2024
Date Received
March 7, 2024
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 by Traferox Technologies, Inc.

  • K260456 — VI°Port™ Liver Preservation System (June 1, 2026)
  • K243870 — X°Port Lung Preservation System; X°Port Lung Preservation Solution (May 1, 2025)

Other clearances for product code KDN

  • 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)
  • K234060 — KIDNEYvault Portable Renal Perfusion System (October 23, 2024)
  • K230193 — Servator P Plus SALF Solution (September 21, 2023)
  • K223874 — BAROguard (August 15, 2023)

FDA data resources