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510(k) K220935

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App by Iren-Medical, Ltd. — Product Code FKX

K220935 is an FDA 510(k) premarket notification submitted by Iren-Medical, Ltd. for the device "Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App". The FDA issued a decision of Substantially Equivalent on December 29, 2022. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2022
Date Received
March 31, 2022
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

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

FDA data resources