# Smiths Medical International Ltd., Luton

- Location (FDA's records): Waukesha, WI
- FDA decisions: 1 (2005–2005): 1 510(k) clearance
- Product codes: BTL (1)
- Predicates its devices cite: 2 (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 whose devices it cites most
- Pneupac, Ltd.: 2 (https://510kreport.com/company/pneupac)

## Firms that cite its devices most
- Airon Corporation: 1 (https://510kreport.com/company/airon)

## Its most-cited devices
- K043495: Babypac (2005), cited by 1

## Recent decisions
- K043495: Babypac (Apr 22, 2005)

Source page: https://510kreport.com/company/smiths-medical-international-luton