Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471, 5C4469
FDA 510(k) K012988 · Baxter Healthcare Corp
510(k) numberK012988
Submission
- Device name
- Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471, 5C4469
- Applicant
- Baxter Healthcare Corp
Mcgaw Park, IL, US - Received
- September 6, 2001
- Decision date
- December 5, 2001
- 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 |
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the…FKX · Traditional | Baxter Healthcare Corporation | 11/19/2020SE |
| 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 |
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Questions and answers
When was Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471, 5C4469 cleared by the FDA?
Homechoice Personal Cycler Peritoneal Dialysis System, Models 5C8310, 5C8302, 5C4471, 5C4469 (K012988) received a 510(k) decision of Substantially Equivalent on December 5, 2001, 90 days after the submission was received.
What is the product code of K012988?
The FDA product code is FKX – System, Peritoneal, Automatic Delivery, a Class II (moderate risk) device regulated under 21 CFR 876.5630.