AirLife DuoTherm Humidification System— 510(k) K231380

Substantially Equivalent

Vyaire Medical, Inc.

FDA 510(k) clearance K231380 for AirLife DuoTherm Humidification System, Substantially Equivalent on 2023-08-10. Applicant: Vyaire Medical, Inc..

Clearance details

Applicant: Vyaire Medical, Inc.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2023-05-12
Decision date: 2023-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mettawa, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.