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United States FDA 510(k) clearance K260270Substantially Equivalent

FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)

United StatesClass 2FindAir Sp. z o.o.Cleared Jun 02, 2026
Verified
Clearance details
K-Number
K260270
View FDA 510(k) Summary PDF View on FDA Database
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Product Code
CAF
View Product Code Classification
Device Class
Class 2
Clearance Type
Traditional
Regulation Number
868.5630
View CFR Regulation
Applicant information
Applicant
FindAir Sp. z o.o.
Contact
Anna Pawlik
Location
Glogowa 26
Kraków 31-235
PL
Medical classification
Medical Specialty
Anesthesiology
Advisory Committee
AN
Dates and decision
Date Received
Jan 28, 2026
Decision Date
Jun 02, 2026
Decision
Substantially Equivalent
Statement / Summary

Summary

About this record

Access comprehensive regulatory information for FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) in the USA medical device market through Pure Global AI's free database. This Class 2 medical device was cleared under FDA 510(k) number K260270 and submitted by FindAir Sp. z o.o.. The clearance decision was Substantially Equivalent on Jun 02, 2026.

This page provides complete clearance details including product code CAF, medical specialty classification (Anesthesiology), and regulatory compliance information from the official FDA OpenFDA database. Pure Global AI offers free access to FDA 510(k) clearances from 1976 to present, helping global MedTech companies navigate USA FDA regulations efficiently.