# K220935: Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App

- Pathway: 510(k) (Traditional)
- Applicant: Iren-Medical, Ltd.
- Decided: Dec 29, 2022 after 273 days
- Product code: FKX (System, Peritoneal, Automatic Delivery)
- Device class: 2
- Regulation: 21 CFR 876.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Intelligent Dialysis Assistant (IDA) is intended for automatic single exchange of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis. All therapies using the Intelligent Dialysis Assistant (IDA) must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis. The patient prescription may include single or multiple exchanges, depending on the patient’s need. The IDA Cartridge is a single-use, sterile cartridge exclusively for use with the IDA. It is intended to interface the IDA with the Twin Bag Set (patient dialysis prescription) and the patient's peritoneal catheter. The Medical Supervision Portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment data to a central database to aid in the review, analysis, and evaluation of patients’ historical treatment results. This Medical Supervision Portal is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways. The IDA Smartphone App is a software medical application intended for patients to review their treatment parameters and review and approve their dialysis prescription provided by the healthcare professional through the Medical Supervision Portal. The user is not intended to take clinical action based on the application output without consultation of a qualified healthcare professional.

Source page: https://510kreport.com/device/K220935
Methodology: https://510kreport.com/methodology