K243920 is an FDA 510(k) clearance for the Purema H Hemoconcentrator - Pediatric, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Medica USA, Inc. (Minnetonka, US). The FDA issued a Cleared decision on September 19, 2025, 273 days after receiving the submission on December 20, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K243920 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 2024 |
| Decision Date | September 19, 2025 |
| Days to Decision | 273 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 |