510(k) K170982 · MEA Pump, Infusion, Pca
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)
| Applicant | Smiths Medical Ads, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 24, 2017 |
| Received | Apr 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170982
| 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 |
| May 7, 2025 | Smiths Medical ASD, Inc. CADD Solis HSPCA Pump
***Updated 5/27/26***
Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope:
PUMP KIT, CADD SOLIS HP Open, Classified |
MEA | None listed |
| May 5, 2025 | Smiths Medical ASD, Inc. CADD-Solis Infusion Pump Models:
1) PUMP KIT, CADD-SOLIS, MDL 2110,
V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51;
2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Open, Classified |
MEA | 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 |
| Aug 3, 2024 | Smiths Medical ASD Inc. CADD-Solis VIP ambulatory Infusion Pumps, Model 2110.
Indicated for the following uses:
Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidur Open, Classified |
MEA | None listed |
| Jan 30, 2023 | Smiths Medical ASD Inc. CADD Administration Set, List Numbers:
1) REF 21-7300-24,
2) REF 21-7301-24
3) REF 21-7302-24,
4) REF 21-7321-24,
5) REF 21-7322-24,
6) REF 21-7323-24,
7) REF 21-7324-24,
8) REF 21-7333-24,
9) Open, Classified |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.