# Smiths Medical MD, Inc.

- Location (FDA's records): St. Paul, MN
- FDA decisions: 20 (2004–2012): 20 510(k) clearances
- Product codes: FPA (4), LJT (4), FRN (4), MRZ (3), LZG (2), MEA (1), DYB (1), FMI (1)
- Predicates its devices cite: 21 (4 its own); citations of its devices by later devices: 22 (4 its own)
- Recalls linked to its devices: 49 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pharmacia Deltec, Inc.: 6 (https://510kreport.com/company/pharmacia-deltec)
- Sims Deltec, Inc.: 2 (https://510kreport.com/company/sims-deltec)
- Medex, Inc.: 2 (https://510kreport.com/company/medex)
- Alaris Medical Systems, Inc.: 2 (https://510kreport.com/company/alaris-medical-systems)
- Pharmacia, Inc.: 1 (https://510kreport.com/company/pharmacia)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Deltec, Inc.: 1 (https://510kreport.com/company/deltec)
- Oscor, Inc.: 1 (https://510kreport.com/company/oscor)

## Firms that cite its devices most
- Smiths Medical Asd, Inc.: 6 (https://510kreport.com/company/smiths-medical-asd)
- Smiths Medical Ads, Inc.: 1 (https://510kreport.com/company/smiths-medical-ads)
- Chengdu Shifeng Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/chengdu-shifeng-medical-technology)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Norfolk Medical: 1 (https://510kreport.com/company/norfolk-medical)
- Animas Corp.: 1 (https://510kreport.com/company/animas)
- Gilero, LLC: 1 (https://510kreport.com/company/gilero)
- Specialized Health Products International, Inc.: 1 (https://510kreport.com/company/specialized-health-products-international)

## Its most-cited devices
- K040636: Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension Set (2004), cited by 3
- K051568: Cadd-MS 3 Ambulatory Infusion Pump (2005), cited by 3
- K070116: Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle (2007), cited by 3
- K072144: Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - Administrator (2008), cited by 2
- K062323: Deltec Cozmo Insulin Infusion Pump with Cozmonitor Blood Glucose Meter, Models 21-1815, 21-1816, 21-1817 (2006), cited by 2
- K060036: Port-a-Cath, Port-a-Cath II, Proport and P.a.S. Port Implantable Venous Access Systems with Dual Layer Catheter (2006), cited by 2

## Recent decisions
- K112407: Smith Medical Peel-Away Sheath Introducers (Feb 9, 2012)
- K111386: Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported Syringes (PSS) (Aug 29, 2011)
- K101180: Gripper Micro Blunt Cannula, Non-Coring Safety Needle (Gripper Micro Needle) Model: 21-3253-24, 21-3258-24, 21-3262-24, (Aug 3, 2010)
- K091181: Lockbox for Use with Medfusion 3000 Series Pumps (Jun 12, 2009)
- K082783: Cadd -Solis Medication Safety Software:  Administrator and Point-of-Care (Dec 17, 2008)
- K081156: Cadd Medication Cassette Reservoir (Jul 18, 2008)
- K080743: Lockbox for Use with Cadd Solis Infusion Pump (Apr 25, 2008)
- K072144: Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - Administrator (Mar 7, 2008)

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