CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
FDA 510(k) clearance K111275 · decided 2013-02-01
Clearance details
- K-number
- K111275
- Device name
- CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
- Applicant
- Smiths Medical Asd, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-06
- Decision date
- 2013-02-01
- Days to decision
- 637 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21- recall (Z-1668-2025) | Smiths Medical ASD, Inc. | 2025-05-07 |
| CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA recall (Z-1682-2025) | Smiths Medical ASD, Inc. | 2025-05-05 |
| smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 2 recall (Z-0466-2025) | Smiths Medical ASD, Inc. | 2024-11-15 |
| CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a com recall (Z-0222-2025) | Smiths Medical ASD Inc. | 2024-10-31 |
| CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indic recall (Z-2421-2024) | Smiths Medical ASD Inc. | 2024-08-03 |
| CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-010 recall (Z-0107-2022) | Smiths Medical ASD Inc. | 2021-10-19 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S018) | Smiths Medical Asd, Inc. | 2013-05-13 |
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S017) | Smiths Medical Asd, Inc. | 2010-04-21 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S016) | Smiths Medical Asd, Inc. | 2009-04-20 |
| PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S015) | Smiths Medical Asd, Inc. | 2007-11-06 |
| PORT-A-CATH EPIDURAL & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S014) | Smiths Medical Asd, Inc. | 2007-08-28 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S013) | Smiths Medical Asd, Inc. | 2007-04-05 |
| PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM (P900052/S012) | Smiths Medical Asd, Inc. | 2002-12-17 |
| PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS (P900052/S011) | Smiths Medical Asd, Inc. | 2002-10-03 |