# Smiths Medical Asd, Inc.

- Location (FDA's records): Keene, NH
- FDA decisions: 53 (1991–2024): 52 510(k) clearances and 1 original PMA approval
- Product codes: FMI (5), JOH (5), DWJ (4), BSP (4), FOZ (3), MEG (3), CAZ (3), BTT (3), CBT (2), DRS (2), PWH (2), BSO (2)
- 510(k) review time since 2016: median 209 days, against 182 for FDA's reviews in the same codes and years (3 of 9 faster)
- Predicates its devices cite: 87 (22 its own); citations of its devices by later devices: 57 (22 its own)
- Recalls linked to its devices: 35 (11 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Smiths Medical MD, Inc.: 6 (https://510kreport.com/company/smiths-medical-md)
- Terumo Medical Corp.: 4 (https://510kreport.com/company/terumo-medical)
- Portex, Inc.: 4 (https://510kreport.com/company/portex)
- Concord/Portex: 3 (https://510kreport.com/company/concord-portex)
- Sims Portex, Inc.: 3 (https://510kreport.com/company/sims-portex)
- Smiths Industries Medical Systems, Inc.: 3 (https://510kreport.com/company/smiths-industries-medical-systems)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 3 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Sims Level 1, Inc.: 2 (https://510kreport.com/company/sims-level-1)

## Firms that cite its devices most
- Smith Medical Asd, Inc.: 3 (https://510kreport.com/company/smith-medical-asd)
- Zyno Medical, LLC: 2 (https://510kreport.com/company/zyno-medical)
- Covidien: 2 (https://510kreport.com/company/covidien)
- Thermedx, LLC: 2 (https://510kreport.com/company/thermedx)
- Intervene Group Limited: 2 (https://510kreport.com/company/intervene-group)
- Teleflexmedical, Inc.: 2 (https://510kreport.com/company/teleflexmedical)
- Smiths Medical Ads, Inc.: 1 (https://510kreport.com/company/smiths-medical-ads)
- PAJUNK GmbH Medizintechnologie: 1 (https://510kreport.com/company/pajunk-medizintechnologie)

## Its most-cited devices
- K111275: Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software (2013), cited by 4
- K083451: Portex Epidural Filter, Model 100/386/010, Various Standard and Custom Trays (2009), cited by 4
- K083641: Bivona Tracheostomy Tubes (2009), cited by 4
- K072080: Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, IR-40, IR-500, IR-600, (2008), cited by 4
- K041399: Hypodermic Needle-Pro Edge Needle Protection Device (2004), cited by 3
- K110053: Correctinject Safety System, Catheter Connector, Filter, Infusion Adaptor, Syringe Kit (2012), cited by 3

## Recent decisions
- K232943: Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe (May 31, 2024)
- K210833: Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula (Nov 26, 2021)
- K211634: Hypodermic Needle-Pro EDGE Safety Device (Aug 26, 2021)
- K192375: Intellifuse Administration and Intellifuse Blood Administration Sets (Sep 18, 2020)
- K181699: Level 1 Convective Warmer (Jul 26, 2018)
- K172800: Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors (Jun 14, 2018)
- K172823: Portex NRFit Epidural Needles (Jun 12, 2018)
- K172410: Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters (Jun 1, 2018)

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