Home / 510(k) Clearances / K212522

510(k) K212522

Lilliput APD System by Fresenius Medical Care Renal Therapies Group, LLC — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2022
Date Received
August 11, 2021
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 Fresenius Medical Care Renal Therapies Group, LLC

  • K252459 — multiFlux 130 (F00013123); multiFlux 160 (F00013124) (February 10, 2026)
  • K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (January 29, 2026)
  • K253518 — FX CorAL 40; FX CorAL 50 (December 18, 2025)
  • K250634 — BCM2-Body Composition Monitor (November 24, 2025)
  • K250471 — AquaC UNO H (November 14, 2025)
  • K251851 — DIASAFEplusUS (F00013010) (October 9, 2025)
  • K252180 — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bi (September 9, 2025)
  • K243237 — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126) (June 13, 2025)
  • K243505 — 5008X Hemodialysis System (May 30, 2025)
  • K243786 — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bi (April 4, 2025)

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)
  • 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)
  • K151525 — Amia Automated PD System with Sharesource (October 9, 2015)