Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)— 510(k) K241268

Substantially Equivalent

Exceleron Medical

FDA 510(k) clearance K241268 for Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS), Substantially Equivalent on 2024-08-02. Applicant: Exceleron Medical.

Clearance details

Applicant: Exceleron Medical
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 2024-05-06
Decision date: 2024-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZE

product code BZE

Death: 4
Malfunction: 910
Other: 1
Total: 915

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.