FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)— 510(k) K260270

Substantially Equivalent

FindAir Sp. z o.o.

FDA 510(k) clearance K260270 for FindAir ONE for pMDI (FAO-MDI-V12-GRE-001), Substantially Equivalent on 2026-06-02. Applicant: FindAir Sp. z o.o..

Clearance details

Applicant: FindAir Sp. z o.o.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2026-01-28
Decision date: 2026-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kraków, PL

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.