Home / 510(k) Clearances / K103220

510(k) K103220

VOYAGER PERITONEAL DIALYSIS SYSTEM by Deka Research & Development Corp. — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2011
Date Received
November 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Deka Research & Development Corp.

  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K250930 — twiist system (April 2, 2025)
  • K250357 — RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (March 11, 2025)
  • K241736 — Remunity 2.0 Pump for Remodulin (treprostinil) Injection (January 16, 2025)
  • K243354 — Remunity System (November 27, 2024)
  • K233557 — HemoCare Hemodialysis System (July 12, 2024)
  • K240920 — HemoCare Bicarbonate Concentrate Set (BCS) (July 12, 2024)
  • K240256 — Remunity System (June 12, 2024)
  • K241178 — DEKA ACE Pump System (May 24, 2024)
  • K234055 — DEKA Loop (March 13, 2024)

Other clearances for product code FKX

  • K250523 — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes S (October 2, 2025)
  • K243371 — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 (May 16, 2025)
  • K220935 — Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supe (December 29, 2022)
  • K222318 — Fresenius Liberty Select Cycler (October 31, 2022)
  • K212522 — Lilliput APD System (April 15, 2022)
  • K212658 — CloudCath Peritoneal Dialysis Drain Set Monitoring System (February 9, 2022)
  • K201867 — Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the (November 19, 2020)
  • K181108 — Fresenius Liberty Select Cycler (May 24, 2018)
  • K173718 — Liberty Cycler Set (May 1, 2018)
  • K171652 — Fresenius Liberty Select Cycler (September 15, 2017)