# Smiths Medical International, Ltd.

- Location (FDA's records): Waukesha, WI
- FDA decisions: 4 (2005–2013): 4 510(k) clearances
- Names in FDA's records: Smiths Medical International , Ltd. (3); Smiths Medical International (1)
- Product codes: BTL (3), BTO (1)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 4 (1 its own)
- Recalls linked to its devices: 8 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pneupac, Ltd.: 1 (https://510kreport.com/company/pneupac)
- O-Two Medical Technologies, Inc.: 1 (https://510kreport.com/company/o-two-medical-technologies)
- Vygon Corp.: 1 (https://510kreport.com/company/vygon)
- Pulmodyne: 1 (https://510kreport.com/company/pulmodyne)
- O-Two Systems Intl., Inc.: 1 (https://510kreport.com/company/o-two-systems-intl)
- Drager Medizintechnik GmbH: 1 (https://510kreport.com/company/drager-medizintechnik)

## Firms that cite its devices most
- Smiths Medical Asd, Inc.: 2 (https://510kreport.com/company/smiths-medical-asd)
- Weinmann Emergency Medical Technology GmbH + Co. KG: 1 (https://510kreport.com/company/weinmann-emergency-medical-technology)

## Its most-cited devices
- K060945: Portex Percutaneous Tracheostomy Kit (2006), cited by 2
- K051322: Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus (2005), cited by 2

## Recent decisions
- K123957: Pneupac Parapac Plus (Sep 16, 2013)
- K071527: Pneupac VR1 Air Mix (Oct 4, 2007)
- K060945: Portex Percutaneous Tracheostomy Kit (Jun 19, 2006)
- K051322: Pneupac Vri Standard, Model Vristdnus, Pneupac Vri Responder, Model Vriresnus (Aug 5, 2005)

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