# Fogless International AB

- Location (FDA's records): Vaggeryd, SE
- FDA decisions: 1 (2013–2013): 1 510(k) clearance
- Product codes: JOH (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Atos Medical AB: 1 (https://510kreport.com/company/atos-medical)

## Its most-cited devices
- K122932: Spiro Speaking Valve with Oxygen Port Spiro Speaking Valve Without Oxygen Port (2013), cited by 1

## Recent decisions
- K122932: Spiro Speaking Valve with Oxygen Port Spiro Speaking Valve Without Oxygen Port (Dec 23, 2013)

Source page: https://510kreport.com/company/fogless-international