# Smiths Medical

- Location (FDA's records): Hythe, Kent, GB
- FDA decisions: 3 (2004–2019): 3 510(k) clearances
- Product codes: BWC (1), JOH (1), BWF (1)
- Predicates its devices cite: 14 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Portex, Inc.: 4 (https://510kreport.com/company/portex)
- Cook, Inc.: 2 (https://510kreport.com/company/cook)
- Smiths Industries Medical Systems, Inc.: 1 (https://510kreport.com/company/smiths-industries-medical-systems)
- Mectra Labs, Inc.: 1 (https://510kreport.com/company/mectra-labs)
- Concord/Portex: 1 (https://510kreport.com/company/concord-portex)
- Mentor Medical Limited: 1 (https://510kreport.com/company/mentor-medical)
- Sims Portex, Inc.: 1 (https://510kreport.com/company/sims-portex)
- Rusch Intl.: 1 (https://510kreport.com/company/rusch-intl)

## Firms that cite its devices most
- Smiths Medical Asd, Inc.: 2 (https://510kreport.com/company/smiths-medical-asd)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)

## Its most-cited devices
- K041348: Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra (2004), cited by 3

## Recent decisions
- K181660: Acapella Choice Blue Vibratory PEP Device (Oct 24, 2019)
- K050166: Portex Emergency Cricothyroidotomy Kit (May 26, 2005)
- K041348: Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single Stage Dilator, Blue Line Ultra (Jul 13, 2004)

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