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510(k) K842305

C.A.P.D. AUTOMATIC HEATER PDH 200 by Medionics International , Ltd. — Product Code FKX

K842305 is an FDA 510(k) premarket notification submitted by Medionics International , Ltd. for the device "C.A.P.D. AUTOMATIC HEATER PDH 200". The FDA issued a decision of Substantially Equivalent on June 25, 1984. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Medionics International , Ltd. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1984
Date Received
June 12, 1984
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 Medionics International , Ltd.

  • K130441 — FALLER STYLET (April 19, 2013)
  • K993149 — PERITONEAL DIALYSIS CATHETERS AND ADAPTERS (April 28, 2000)
  • K994218 — EASY CARE AND TUBING SETS (February 10, 2000)
  • K945567 — QC CAP (February 7, 1995)
  • K910173 — SELECTRA AND TUBING SETS (January 13, 1992)
  • K883393 — CAPD DISPOSABLE Y SYSTEM - DY SET (November 3, 1988)
  • K831766 — MICROSTAR VCI (October 14, 1983)
  • K832141 — MICROSTAR VC1 VOLUMETRIC CYCLER (October 14, 1983)
  • K821328 — C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP (July 28, 1982)

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)

FDA data resources