FL-10000U Respiratory Humidifier— 510(k) K251448

Substantially Equivalent

Flexicare Medical Limited.

FDA 510(k) clearance K251448 for FL-10000U Respiratory Humidifier, Substantially Equivalent on 2026-01-16. Applicant: Flexicare Medical Limited..

Clearance details

Applicant: Flexicare Medical Limited.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2025-05-09
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rhondda Cynon Taf, 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.