510(k) K201867 ยท FKX System, Peritoneal, Automatic Delivery
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
| Applicant | Baxter Healthcare Corporation, Round Lake IL, US |
| Decision | Substantially Equivalent, Nov 19, 2020 |
| Received | Jul 7, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201867
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2025 | Vantive US Healthcare LLC Sharesource Connectivity Platform for Use with Homechoice Claria
Product Code 5CGM01
software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM) Open, Classified |
FKX | None listed |
| Apr 1, 2023 | Baxter Healthcare Corporation Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges. Open, Classified |
FKX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.