FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE— 510(k) K161314

Substantially Equivalent

Flexicare Medical Limited.

FDA 510(k) clearance K161314 for FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE, Substantially Equivalent on 2016-07-06. Applicant: Flexicare Medical Limited..

Clearance details

Applicant: Flexicare Medical Limited.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2016-05-11
Decision date: 2016-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain Ash, GB

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.