K201867 is an FDA 510(k) clearance for the Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System. This device is classified as a System, Peritoneal, Automatic Delivery (Class II - Special Controls, product code FKX).
Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on November 19, 2020, 135 days after receiving the submission on July 7, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K201867 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2020 |
| Decision Date | November 19, 2020 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FKX — System, Peritoneal, Automatic Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |