Cleared Traditional

K220935 - Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220935 · Iren-Medical, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
273d
Days
Class 2
Risk

K220935 is an FDA 510(k) clearance for the Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical S.... Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Iren-Medical, Ltd. (Or Aquiva, IL). The FDA issued a Cleared decision on December 29, 2022 after a review of 273 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Iren-Medical, Ltd. devices

Submission Details

510(k) Number K220935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2022
Decision Date December 29, 2022
Days to Decision 273 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 130d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKX System, Peritoneal, Automatic Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Insight Medical Consulting, LLC
Wanda Carpinella

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FKX System, Peritoneal, Automatic Delivery

All 82
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K220935.
Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1)
K250523 · Simergent, LLC · Oct 2025
Byonyks X-1 APD Cycler
K243371 · Byonyks Pvt, Ltd. · May 2025
Fresenius Liberty Select Cycler
K222318 · Fresenius Medical Care Renal Therapies Group, LLC · Oct 2022
Lilliput APD System
K212522 · Fresenius Medical Care Renal Therapies Group, LLC · Apr 2022
CloudCath Peritoneal Dialysis Drain Set Monitoring System
K212658 · Cloudcath · Feb 2022