K212216 is an FDA 510(k) clearance for the Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set. This device is classified as a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II - Special Controls, product code KDI).
Submitted by Baxter Healthcare Corporation (Deerfield Lake, US). The FDA issued a Cleared decision on April 1, 2022, 259 days after receiving the submission on July 16, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K212216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2021 |
| Decision Date | April 01, 2022 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5860 |