Home / 510(k) Clearances / K992209

510(k) K992209

CUSTODIOL by Dr. Franz Kohler Chemie GmbH — Product Code KDN

K992209 is an FDA 510(k) premarket notification submitted by Dr. Franz Kohler Chemie GmbH for the device "CUSTODIOL". The FDA issued a decision of Substantially Equivalent on December 10, 1999. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. Dr. Franz Kohler Chemie GmbH has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1999
Date Received
June 30, 1999
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 Dr. Franz Kohler Chemie GmbH

  • K192408 — Custodiol HTK Solution (April 24, 2020)
  • K043461 — CUSTODIOL (February 28, 2005)
  • K032794 — CUSTODIOL (April 5, 2004)
  • K020924 — CUSTODIOL HTK SOLUTION (January 6, 2003)

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