510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220935Substantially Equivalent

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App

Iren-Medical, Ltd., Or Aquiva, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K220935 is the FDA 510(k) clearance record for Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App, a class II device, cleared for Iren-Medical, Ltd. on under FDA product code FKX (System, Peritoneal, Automatic Delivery). FDA records list one 510(k) clearance for Iren-Medical, Ltd. As of , FDA records show no recalls naming K220935.

Clearance record

Decision date
Received
(273 days to decision)
Product code
FKX System, Peritoneal, Automatic Delivery
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Iren-Medical, Ltd. 14 Hallan St., Or Aquiva, IL
510(k) summary
Statement
Third party review
No

Clearances, product code FKX

Trailing 12 months

FDA records hold no clearances under product code FKX in the trailing twelve months.

FDA records show no clearances under product code FKX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FKX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260