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510(k) K013575

KPS-I, THE KIDNEY PERFUSION SOLUTION by Organ Recovery Systems, Inc. — Product Code KDN

K013575 is an FDA 510(k) premarket notification submitted by Organ Recovery Systems, Inc. for the device "KPS-I, THE KIDNEY PERFUSION SOLUTION". The FDA issued a decision of Substantially Equivalent on January 25, 2002. 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
January 25, 2002
Date Received
October 29, 2001
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)
  • K021362 — LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) (July 31, 2003)
  • K022391 — MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION (October 21, 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