K240447 is an FDA 510(k) clearance for the ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000). This device is classified as a Warmer, Peritoneal Dialysate (Class II - Special Controls, product code MLW).
Submitted by Thermasolutions, LLC (White Bear Lake, US). The FDA issued a Cleared decision on May 5, 2025, 445 days after receiving the submission on February 15, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K240447 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | February 15, 2024 |
| Decision Date | May 05, 2025 |
| Days to Decision | 445 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MLW - Warmer, Peritoneal Dialysate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |