MLW
- Product code
- MLW
- Device name
- Warmer, Peritoneal Dialysate
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5630
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 6 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240447 | 2025-05-05 | Thermasolutions, LLC | ThermoChem HT-2000 System and Intraperitoneal Hypert… | FDA |
Official FDA classification page: MLW
Classification and pathway per current FDA publications. Data from openFDA (CC0).