Data / Medical devices / United States / Exceleron Medical, LLC
Exceleron Medical, LLC: FDA-registered device maker in Saint Paul, MN, United States, 1 510(k) clearance
Exceleron Medical, LLC is registered with the FDA (registration 3007709321) in Saint Paul, MN, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 2, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007709321
- Address
- 5000 Township Pkwy, Saint Paul, MN, United States, 55110
- Owner or operator
- Exceleron Medical (10038616)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- June 14, 2012
- Registered through
- 2026
- Brand names listed
- SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS), Thermalite Heated CPAP Tube
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Contract manufacturer | accessdata.fda.gov |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | 2 | Manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 2, 2024 | K241268 | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | BZE | Substantially Equivalent | Exceleron Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Updated August 2, 2024. 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.