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510(k) K894838

HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB by Baxter Healthcare Corp — Product Code FKP

K894838 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB". The FDA issued a decision of Substantially Equivalent on September 7, 1989. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1989
Date Received
July 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K130531 — ULTRAFUSE (April 8, 2014)
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  • K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENS (March 1, 2013)
  • K123874 — INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS (January 10, 2013)
  • K123868 — INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, (January 8, 2013)

Other clearances for product code FKP

  • K181991 — NxStage Connected Health System (September 26, 2018)
  • K131739 — NXSTAGE CONNECTED HEALTH SYSTEM (October 10, 2013)
  • K130460 — NXSTAGE DOSING CALCULATOR (July 11, 2013)
  • K040074 — ONEVIEW INTERFACE (April 8, 2004)
  • K021060 — FRESENIUS ICARE MONITORING SYSTEM (November 13, 2002)
  • K003615 — STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS (February 1, 2001)
  • K992255 — CKHEMO, MODEL CKHEMO VERSION 1.0 (November 30, 1999)
  • K964264 — HIGH RANGE PEROXIDE TEST STRIP (June 16, 1997)
  • K955423 — PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (June 13, 1996)
  • K953854 — WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE (March 11, 1996)

FDA data resources