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510(k) K091656

SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L by Organ Recovery Systems, Inc. — Product Code KDL

K091656 is an FDA 510(k) premarket notification submitted by Organ Recovery Systems, Inc. for the device "SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L". The FDA issued a decision of Substantially Equivalent on March 11, 2010. The device falls under product code KDL (Set, Perfusion, Kidney, Disposable), 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
March 11, 2010
Date Received
June 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Organ Recovery Systems, Inc.

  • K021362 — LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) (July 31, 2003)
  • 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 KDL

  • K241239 — OrganProtex HTK Solution (January 24, 2025)
  • K221387 — BEL-GEN Cold Storage Solution (June 14, 2022)
  • K221386 — PERF-GEN Pulsatile Perfusion Solution (June 14, 2022)
  • K211842 — Servator M SALF Solution (December 20, 2021)
  • K192408 — Custodiol HTK Solution (April 24, 2020)
  • K170150 — Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml (October 20, 2017)
  • K121736 — PERF-GEN PULSATILE PERFUSION SOLUTION (August 16, 2013)
  • K121618 — BEL-GEN COLD STORAGE SOLUTION (June 14, 2013)
  • K043461 — CUSTODIOL (February 28, 2005)
  • K020924 — CUSTODIOL HTK SOLUTION (January 6, 2003)

FDA data resources