Comfort Flo Humidification System— 510(k) K162242

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K162242 for Comfort Flo Humidification System, Substantially Equivalent on 2017-01-19. Applicant: Teleflexmedical, Inc..

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2016-08-10
Decision date: 2017-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, 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.