MLW — Warmer, Peritoneal Dialysate Class II
FDA product code MLW covers "Warmer, Peritoneal Dialysate", a Class II medical device regulated under 21 CFR 876.5630. Submissions are reviewed by the Gastroenterology, Urology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MLW
- Device Class
- Class II
- Regulation Number
- 876.5630
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240447 | thermasolutions | ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit ( | May 5, 2025 |
| K131583 | thermasolutions | THERMOCHEM HT-2000 | October 3, 2013 |
| K020542 | stickman industries | DAYTRIPPER DIALYSATE WARMER | September 27, 2002 |
| K993330 | hemocleanse | THERMOCHEM-HT SYSTEM | December 30, 1999 |
| K964825 | impact case technologies | FREEDOM TRAVELLER | May 19, 1997 |
| K933619 | general medical mfg | PD-PAK | February 22, 1994 |