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510(k) K021362

LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) by Organ Recovery Systems, Inc. — Product Code KDN

K021362 is an FDA 510(k) premarket notification submitted by Organ Recovery Systems, Inc. for the device "LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)". The FDA issued a decision of Substantially Equivalent on July 31, 2003. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. Organ Recovery Systems, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2003
Date Received
April 30, 2002
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 Organ Recovery Systems, Inc.

  • K091656 — SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L (March 11, 2010)
  • K022391 — MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION (October 21, 2002)
  • K013575 — KPS-I, THE KIDNEY PERFUSION SOLUTION (January 25, 2002)

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)
  • K240650 — LungProtect (November 26, 2024)
  • K234060 — KIDNEYvault Portable Renal Perfusion System (October 23, 2024)
  • K230193 — Servator P Plus SALF Solution (September 21, 2023)

FDA data resources