K241268 is an FDA 510(k) clearance for the Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS). This device is classified as a Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer (Class II - Special Controls, product code BZE).
Submitted by Exceleron Medical (St. Paul, US). The FDA issued a Cleared decision on August 2, 2024, 88 days after receiving the submission on May 6, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5270.
| 510(k) Number | K241268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2024 |
| Decision Date | August 02, 2024 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZE - Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5270 |