MLW
6 FDA 510(k) clearances · Product code
218 daysmedian time to decision
445 days90th percentile
6clearances measured
FDA profile
- Official device name
- Warmer, Peritoneal Dialysate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2004: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) (K240447) | Thermasolutions, LLC | 2025-05-05 |
| THERMOCHEM HT-2000 (K131583) | Thermasolutions, Inc. | 2013-10-03 |
| DAYTRIPPER DIALYSATE WARMER (K020542) | Stickman Industries, Inc. | 2002-09-27 |
| THERMOCHEM-HT SYSTEM (K993330) | Hemocleanse, Inc. | 1999-12-30 |
| FREEDOM TRAVELLER (K964825) | Impact Case Technologies, Inc. | 1997-05-19 |
| PD-PAK (K933619) | General Medical Mfg. Co. | 1994-02-22 |
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Every clearance here is in the API, with alerts when new ones post.