Data / Medical devices / United States / Thermasolutions LLC.
Thermasolutions LLC.: FDA-registered device maker in White Bear Lake, MN, United States, 5 510(k) clearances
Thermasolutions LLC. is registered with the FDA (registration 3005699784) in White Bear Lake, MN, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 5, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005699784
- Address
- 1889 Buerkle Rd, White Bear Lake, MN, United States, 55110
- Owner or operator
- THERMASOLUTIONS LLC. (9082263)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 6, 2006
- Registered through
- 2026
- Brand names listed
- FLW-0010 Lasso Tubing, FLW-0111 Long Lasso Tubing, FLW-0120 Inflow Tubing, HurriChem Device Kit, PAK-0112 Inflow and Outflow Tubing Pack, THERMOCHEM HT-1000, Temperature Probe TMP-1304, Temperature Probe TMP-1308 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Irrigation | GBX | 1 | Specification developer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Warmer, Peritoneal Dialysate | MLW | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 5, 2025 | K240447 | ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) | MLW | Unknown | Thermasolutions, LLC | accessdata.fda.gov |
| December 6, 2022 | K222575 | HurriChem Device Kit | GCJ | Substantially Equivalent | Thermasolutions, LLC | accessdata.fda.gov |
| October 3, 2013 | K131583 | THERMOCHEM HT-2000 | MLW | Substantially Equivalent | Thermasolutions, Inc. | accessdata.fda.gov |
| November 18, 2010 | K101244 | SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE | FLL | Substantially Equivalent | Truer Medical, Inc. | accessdata.fda.gov |
| December 30, 1999 | K993330 | THERMOCHEM-HT SYSTEM | MLW | Substantially Equivalent | Hemocleanse, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Irrigation
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Warmer, Peritoneal Dialysate
- All makers of Continuous Measurement Thermometer
Updated May 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.