THERMOCHEM HT-2000
FDA 510(k) clearance K131583 · decided 2013-10-03
Clearance details
- K-number
- K131583
- Device name
- THERMOCHEM HT-2000
- Applicant
- Thermasolutions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-05-31
- Decision date
- 2013-10-03
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- MLW
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) (K240447) | Thermasolutions, LLC | 2025-05-05 |
| DAYTRIPPER DIALYSATE WARMER (K020542) | Stickman Industries, Inc. | 2002-09-27 |
| THERMOCHEM-HT SYSTEM (K993330) | Hemocleanse, Inc. | 1999-12-30 |
| FREEDOM TRAVELLER (K964825) | Impact Case Technologies, Inc. | 1997-05-19 |
| PD-PAK (K933619) | General Medical Mfg. Co. | 1994-02-22 |
Recalls involving this device
No recalls on record reference this clearance.