FL-10000U Respiratory Humidifier— 510(k) K251448
Substantially EquivalentFlexicare Medical Limited.
FDA 510(k) clearance K251448 for FL-10000U Respiratory Humidifier, Substantially Equivalent on 2026-01-16. Applicant: Flexicare Medical Limited.. Device class: 2.
Clearance details
- Applicant
- Flexicare Medical Limited.
- Product code
- Code BTT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rhondda Cynon Taf, GB
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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, through . 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.