510(k) K072144 ยท MEA Pump, Infusion, Pca
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR
| Applicant | Smiths Medical MD, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Mar 7, 2008 |
| Received | Aug 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072144
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2025 | Smiths Medical ASD, Inc. CADD-Solis HPCA Ambulatory Infusion Pump;
Model/Number:
21-2111-0402-09-KYO
21-2111-0402-09-KYO
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP
21-2111-0300-09_LOAN
CADD SOLIS PIB PUMP FOR CLI Open, Classified |
MEA | None listed |
| Aug 3, 2024 | Smiths Medical ASD Inc. CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses:
Indicated for the following uses:
Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into a Open, Classified |
MEA | None listed |
| Jun 18, 2015 | Smiths Medical ASD, Inc. CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0.
Provide measured drug therapy to patients in hospital or outpatient sett Terminated |
MEA | None listed |
| Nov 1, 2014 | Smiths Medical ASD, Inc. CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01.
Product Usage:
The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create Terminated |
MEA | None listed |
| Oct 4, 2011 | Smiths Medical ASD, Inc. Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only.
Indicated for intravenous, intra-arterial, subcutaneous, intraperitone Terminated |
MEA | None listed |
| Feb 3, 2011 | Smiths Medical ASD, Inc. Smiths Medical, CADD-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder Number 21-2101-00, 21-2101-0100-50, 21-2101-0100-51, 21-2101-0200-02, 21-2101-0200-03, 21-2111-0100-51, 21-211 Terminated |
MEA | None listed |
| Mar 11, 2010 | Smiths Medical ASD, Inc. Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for use with Smiths Medical CADD-Solis ambulatory infusion pumps, Model 2100. These cords were sold as an access Terminated |
MEA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.