MLWClass IILife-sustaining
Warmer, Peritoneal Dialysate
Gastroenterology, Urology · 21 CFR 876.5630
MDR events10All time
Recalls0All time
Registered firms9Currently listed
510(k) clearances6All time
Recent MDR events
10 adverse event reports on file
- HIPEC PUMPNov 13, 2025Malfunction23542589
- THERMOCHEMMay 5, 2025MalfunctionThermasolutions, Inc.21960765
- THERMASOLUTIONS, INC.Jan 20, 2017MalfunctionThermasolutions, Inc.MW5067378
- THERMOCHEMDec 22, 2011MalfunctionThermasolutions3005699784-2011-00001
- THERMOCHEMDec 22, 2011MalfunctionThermasolutions3005699784-2011-00002
- *Nov 15, 2011MalfunctionThermasolutions2366898
- *Nov 15, 2011MalfunctionThermasolutions2366914
- THERMOCHEMSep 1, 2009MalfunctionThermasolutions1478197
- MENICON Z RIGID GAS PERMEABLE (RGP) CONTACT LENSApr 27, 2004OtherMenicon Co. Ltd.3003515967-2004-00003
- Unnamed deviceApr 27, 2004Other9614761-2004-00003
Event type breakdown
Malfunction8
Other2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Thermasolutions, LLCMay 5, 2025
K240447 · ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)
- Thermasolutions, Inc.Oct 3, 2013
K131583 · THERMOCHEM HT-2000
- Stickman Industries, Inc.Sep 27, 2002
K020542 · DAYTRIPPER DIALYSATE WARMER
- Hemocleanse, Inc.Dec 30, 1999
K993330 · THERMOCHEM-HT SYSTEM
- Impact Case Technologies, Inc.May 19, 1997
K964825 · FREEDOM TRAVELLER
- General Medical Mfg. Co.Feb 22, 1994
K933619 · PD-PAK