Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - Administrator
FDA 510(k) K072144 · Smiths Medical MD, Inc.
510(k) numberK072144
Submission
- Device name
- Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - Administrator
- Applicant
- Smiths Medical MD, Inc.
St. Paul, MN, US - Received
- August 2, 2007
- Decision date
- March 7, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEA – Pump, Infusion, Pca
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K043299 | Medley Pca Module, Model 8120MEA · Traditional | Alaris Medical Systems, Inc. | 12/10/2004SE |
| K043256 | Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System…MEA · Special | Hospira, Inc. | 12/06/2004SE |
| K042800 | Lifecare Pca Infusion System with Hospira Mednet SoftwareMEA · Traditional | Hospira, Inc. | 10/18/2004SE |
| K033054 | Harvard 1 Syringe Pump/Harvard 1 with Pca Syringe PumpMEA · Traditional | Harvard Clinical Technology | 12/16/2003SE |
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| K082783 | Cadd -Solis Medication Safety Software: Administrator and Point-Of-CareMRZ · Traditional | 12/17/2008SE |
| K081156 | Cadd Medication Cassette ReservoirFPA · Traditional | 07/18/2008SE |
| K080743 | Lockbox for Use with Cadd Solis Infusion PumpFRN · Traditional | 04/25/2008SE |
| K072955 | Cadd-Sentry Pro Medication Safety Software-Administrator (21-6275), Point of Care…MRZ · Traditional | 02/13/2008SE |
| K072657 | Power Port-A-Cath, Cath II, and P.A.S. Port T2 Power P.A.C. Implantable Venous Access…LJT · Traditional | 12/14/2007SE |
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Questions and answers
When was Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - Administrator cleared by the FDA?
Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - Administrator (K072144) received a 510(k) decision of Substantially Equivalent on March 7, 2008, 218 days after the submission was received.
What is the product code of K072144?
The FDA product code is MEA – Pump, Infusion, Pca, a Class II (moderate risk) device regulated under 21 CFR 880.5725.