510(k) K111275 ยท FRN Pump, Infusion
CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
| Applicant | Smiths Medical Asd, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Feb 1, 2013 |
| Received | May 6, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111275
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2025 | Smiths Medical ASD, Inc. CADD-Solis VIP Ambulatory Infusion Pump;
Model/Number:
21-2120-0100-02
21-2120-0100-03
21-2120-0100-06
21-2120-0100-232
21-2120-0100-233
21-2120-0100-50
21-2120-0100-51
21-2120-0100-95
21-2120-0102- Open, Classified |
FRN | None listed |
| May 5, 2025 | Smiths Medical ASD, Inc. CADD Solis VIP Ambulatory Infusion Pump Models:
1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL
MODE, 1/EA, Model Number: 21-2127-0105-01;
2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLI Open, Classified |
FRN | None listed |
| Nov 15, 2024 | Smiths Medical ASD, Inc. smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps Open, Classified |
MEA | None listed |
| Oct 31, 2024 | Smiths Medical ASD Inc. CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-020 Open, Classified |
FRN | None listed |
| Aug 3, 2024 | Smiths Medical ASD Inc. CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127)
Indicated for the following uses:
Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into Open, Classified |
FRN | None listed |
| Oct 19, 2021 | Smiths Medical ASD Inc. CADD-Solis VIP ambulatory infusion pump, Model Numbers:
a. 21-2120-0105-02L
b. 21-2120-0105-03L
c. 21-2120-0105-06L
d. 21-2120-0105-07L
e. 21-2120-0105-08L
f. 21-2120-0105-12L
g. 21-2120-0105-13L
h. 2 Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.