510(k) K220935
- Device
- Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App
- Applicant
- Iren-Medical, Ltd.
- 510(k) number
- K220935
- Product code
- FKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-29
- Date received
- 2022-03-31
- Regulation
- 876.5630
- Classification name
- System, Peritoneal, Automatic Delivery
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Hezkiah Tsoory
- Address
- 14 Hallan St. Or Aquiva IL
FDA Registration Numbers#
- 9610270
- 1650907
- 3006950086
- 3033589330
- 9612052
- 9680579
- 3030306055
- 3006755813
- 9680340
- 1649518
- 3003865400
- 3012494290
- 1721676
- 3010421104
- 1721504
- 3038277270
- 1724474
- 2132111
- 3003537036
- 2314912
- 8030665
- 3015335038
- 3012536737
- 3015225571
- 2030624
- 3002907620
- 3039353681
- 3038195011
- 3015882716
- 3032828299
- 3004111573
- 3031565407
- 9612057
- 2133641
- 3003504604
- 3015309643
- 1225714
- 1319639
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FKX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250523 | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) | Simergent, LLC | 2025-10-02 |
| K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 | Byonyks Pvt, Ltd. | 2025-05-16 |
| K222318 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-31 |
| K212522 | Lilliput APD System | Fresenius Medical Care Renal Therapies Group, LLC | 2022-04-15 |
| K212658 | CloudCath Peritoneal Dialysis Drain Set Monitoring System | Cloudcath | 2022-02-09 |
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System | Baxter Healthcare Corporation | 2020-11-19 |
| K181108 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-24 |
| K173718 | Liberty Cycler Set | Fresenius Medical Care Renal Therapies Group, LLC | 2018-05-01 |
| K171652 | Fresenius Liberty Select Cycler | Fresenius Medical Care Renal Therapies Group, LLC | 2017-09-15 |
| K151525 | Amia Automated PD System with Sharesource | Deka Research and Development | 2015-10-09 |
| K141145 | LIBERTY PDX CYCLER | Fresenius Medical Care Renal Therapies Group, LLC | 2014-07-30 |
| K123630 | FRESENIUS LIBERTY CYCLER | Fresenius Medical Care North America, Design Cente | 2013-09-09 |
| K124018 | AMIA AUTOMATED PD SYSTEM | Deka Research & Development Corp. | 2013-06-14 |
| K103220 | VOYAGER PERITONEAL DIALYSIS SYSTEM | Deka Research & Development Corp. | 2011-07-29 |
| K102936 | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R | Baxter Healthcare Corp | 2011-03-30 |