# K260270: FindAir ONE for pMDI  (FAO-MDI-V12-GRE-001)

- Pathway: 510(k) (Traditional)
- Applicant: FindAir Sp. z o.o.
- Decided: Jun 2, 2026 after 125 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K823423 (1982). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223367: Ochsner Connected Inhaler Sensor, Ochsner Clinic Foundation (2023) Summary page 5.

## Indications for use
The purpose of FindAir ONE for pMDI FOMDI10 is to collect information on the use of the pMDI to support the inhalation therapy of targeted respiratory diseases. The product is aimed at patients and professionals (physicians, researchers) who wish to collect data on the use of inhalers. The FindAir ONE for pMDI FOMDI10 may also be used to send data to remote therapeutic monitoring systems (RTM). The product is intended for adult patients and people under adult care (both children older than 2 years of age and adults requiring supervision). The product is intended for multiple use by single user. Up to 127 uses of the inhaler can be recorded and stored in FindAir ONE for pMDI FOMDI10. FindAir ONE for pMDI FOMDI10 can be used in indoor and outdoor settings such as at home, at work, in the environment of specialist clinics, etc. The product is not intended for diagnosis or treatment and does not replace diagnosis by a doctor or treatment prescribed by a doctor. The FindAir ONE for pMDI FOMDI10 device complies with the requirements of IEC 60601-1 as a product with a type BF applied part. The app, FindAir Viewer, is designed for iOS and Android (mobile only), enabling: - Connection to the FindAir ONE for pMDI FOMDI10 device - Reading data from the FindAir ONE for FOMDI10 devices (battery status, number of stored events, total number of clicks, total operating time, MAC address). - Presentation of this data in an easy-to-read form to the user. - Warning of low battery status - Transmits usage events from device The FindAir Viewer application will be made available to users via the Apple App Store and Google Play, It is intended to be used exclusively with the FindAir ONE for pMDI FOMDI10 device and is provided to customers as part of the product package. Designed for single-patient use, it assists professionals (physicians, researchers) and patients in documenting and monitoring the use of their prescribed pMDI device. Parameters of the metal canister compatible with FindAir ONE for pMDI FOMDI10: • External shape of the canister: round • Minimum canister diameter: 20.5 mm • Maximum canister diameter: 23.5 mm • Protruding above the housing by at least 7 mm

Source page: https://510kreport.com/device/K260270
Methodology: https://510kreport.com/methodology