Warmer, Peritoneal Dialysate
The Peritoneal Dialysate Warmer is a device used to heat peritoneal dialysis solution to body temperature before it is infused into the peritoneal cavity during dialysis, improving patient comfort and reducing the risk of hypothermia-related complications during renal replacement therapy. Classified as a Class 2 device under 21 CFR 876.5630 within the Gastroenterology and Urology specialty, it requires 510(k) premarket notification. It carries a life-sustaining flag, reflecting its role in supporting patients who depend on dialysis for kidney function.
Basic Information
- Product Code
- MLW
- Device Class
- FDA class 2
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240447 | ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) | May 05, 2025 | Unknown | Thermasolutions, LLC |
| K131583 | THERMOCHEM HT-2000 | Oct 03, 2013 | Substantially Equivalent | Thermasolutions, Inc. |
| K020542 | DAYTRIPPER DIALYSATE WARMER | Sep 27, 2002 | Substantially Equivalent | Stickman Industries, Inc. |
| K993330 | THERMOCHEM-HT SYSTEM | Dec 30, 1999 | Substantially Equivalent | Hemocleanse, Inc. |
| K964825 | FREEDOM TRAVELLER | May 19, 1997 | Substantially Equivalent | Impact Case Technologies, Inc. |
| K933619 | PD-PAK | Feb 22, 1994 | Substantially Equivalent | General Medical Mfg. Co. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.