Panels › Gastroenterology, Urology › Product code MLW · Class 2
Warmer, Peritoneal Dialysate
Regulation 876.5630
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MLW
| Company | 510(k)s | Recalls |
|---|---|---|
| Thermasolutions, Inc. | 2 | 0 |
| General Medical Mfg. Co. | 1 | 0 |
| Hemocleanse, Inc. | 1 | 0 |
| Impact Case Technologies, Inc. | 1 | 0 |
| Stickman Industries, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 5, 2025 | K240447 | ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) Thermasolutions, LLC | MLW |
| Oct 3, 2013 | K131583 | THERMOCHEM HT-2000 Thermasolutions, Inc. | MLW |
| Sep 27, 2002 | K020542 | DAYTRIPPER DIALYSATE WARMER Stickman Industries, Inc., CA | MLW |
| Dec 30, 1999 | K993330 | THERMOCHEM-HT SYSTEM Hemocleanse, Inc. | MLW |
| May 19, 1997 | K964825 | FREEDOM TRAVELLER Impact Case Technologies, Inc., CA | MLW |
| Feb 22, 1994 | K933619 | PD-PAK General Medical Mfg. Co. | MLW |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.