# Smiths Industries Medical Systems, Inc.

- Location (FDA's records): Keene, NH
- FDA decisions: 23 (1990–1998): 22 510(k) clearances and 1 original PMA approval
- Product codes: FMI (4), JOH (4), JKA (3), FOZ (2), BTR (2), LLX (1), FLL (1), CAZ (1), CBI (1), BSO (1), FMJ (1), BYE (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 19 (1 its own)
- Recalls linked to its devices: 41 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Concord/Portex: 2 (https://510kreport.com/company/concord-portex)

## Firms that cite its devices most
- Portex, Inc.: 4 (https://510kreport.com/company/portex)
- Mentor Medical Limited: 3 (https://510kreport.com/company/mentor-medical)
- Smiths Medical Asd, Inc.: 3 (https://510kreport.com/company/smiths-medical-asd)
- Rusch Intl.: 2 (https://510kreport.com/company/rusch-intl)
- Sims Portex, Inc.: 2 (https://510kreport.com/company/sims-portex)
- Engineered Medical Systems: 1 (https://510kreport.com/company/engineered-medical-systems)
- Smiths Medical: 1 (https://510kreport.com/company/smiths-medical)
- Rusch, Inc.: 1 (https://510kreport.com/company/rusch)

## Its most-cited devices
- K934465: Dic Tracheostomy Tube and Portex Blue Line (1994), cited by 4
- K962175: Portex Adjustable Flange Tracheostomy Tube (1997), cited by 3
- K965017: Regional Anesthesia Trays (1997), cited by 2
- K936133: Percutaneous Tracheostomy Kit (1994), cited by 2
- K960429: Per-Fit Percutaneous Tracheostomy Kit W/Portex       Tracheostmy Tube & Disp. Inner Cannula (1996), cited by 2
- K935603: Extracorporeal Temperature Sensor (1994), cited by 1

## Recent decisions
- K972385: Fenestrated Flexible D.I.C. Tracheostomy Tube Cuffed (Jan 20, 1998)
- K965017: Regional Anesthesia Trays (Mar 14, 1997)
- K962175: Portex Adjustable Flange Tracheostomy Tube (Jan 17, 1997)
- K962931: Sims Pro-Vent 250 (500) Plus Arterial Blood Sampling Kit (Oct 21, 1996)
- K963570: Sims Adult Lumbar Puncture Kit (4800-20,4801-20,4806-22,4807-22) (Oct 18, 1996)
- K960429: Per-Fit Percutaneous Tracheostomy Kit W/Portex       Tracheostmy Tube & Disp. Inner Cannula (May 2, 1996)
- K953485: Sims Cpap System (Oct 26, 1995)
- K953483: Sims Blue Line Endobronchial Tube (Oct 24, 1995)

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