Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
FDA 510(k) K201867 · Baxter Healthcare Corporation
510(k) numberK201867
Submission
- Device name
- Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
- Applicant
- Baxter Healthcare Corporation
Round Lake, IL, US - Received
- July 7, 2020
- Decision date
- November 19, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250523 | Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard…FKX · Traditional | Simergent, LLC | 10/02/2025SE |
| K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1FKX · Traditional | Byonyks Pvt, Ltd. | 05/16/2025SE |
| K220935 | Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision…FKX · Traditional | Iren-Medical, Ltd. | 12/29/2022SE |
| K222318 | Fresenius Liberty Select CyclerFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 10/31/2022SE |
| K212522 | Lilliput APD SystemFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 04/15/2022SE |
| K212658 | CloudCath Peritoneal Dialysis Drain Set Monitoring SystemFKX · Traditional | Cloudcath | 02/09/2022SE |
| K181108 | Fresenius Liberty Select CyclerFKX · Special | Fresenius Medical Care Renal Therapies Group, LLC | 05/24/2018SE |
| K173718 | Liberty Cycler SetFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/01/2018SE |
| K171652 | Fresenius Liberty Select CyclerFKX · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 09/15/2017SE |
| K151525 | Amia Automated PD System with SharesourceFKX · Traditional | Deka Research and Development | 10/09/2015SE |
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Questions and answers
When was Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System cleared by the FDA?
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System (K201867) received a 510(k) decision of Substantially Equivalent on November 19, 2020, 135 days after the submission was received.
What is the product code of K201867?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.