K102936 is an FDA 510(k) clearance for the HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R. This device is classified as a System, Peritoneal, Automatic Delivery (Class II - Special Controls, product code FKX).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on March 30, 2011, 177 days after receiving the submission on October 4, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K102936 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2010 |
| Decision Date | March 30, 2011 |
| Days to Decision | 177 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 |