510(k) · Cleared
Recalled · Class I · 2025Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · FRN Pump, Infusion
Cleared on Feb 1, 2013 as substantially equivalent to K072144 (Smiths Medical MD, Inc., 2008) and 2 other predicates after a 637-day review. Its family tree reaches back 1 generation to 1996. 6 of the 11 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 6 times, including 5 Class I recalls.
- Decided
- Feb 1, 2013
- Review
- 637 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 6 (5 Class I)
- Predicates
- 3
Its longest line of descent runs back 1 generation to K960826 (1996). 3 ancestors in all. 7 later devices descend from it, 4 citing it directly. 6 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK960826 Cadd-Prizm Model 6100 PumpSims Deltec, Inc. · 1996 · Recalled
- This deviceK111275 Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication…Smiths Medical Asd, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK130394 Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK170982 CADD®- Solis Ambulatory Infusion Pump with Wireless Communication…Smiths Medical Ads, Inc. · 2017 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK232793 Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES)…Zevex, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK140783 Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK242660 Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES)…Zevex, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K072144 Cadd -Solis Ambulatory Infusion Pump and Cadd…direct predicate · 2008
- K153193 Halo II Ambulatory Infusion System (also with…cites it directly · 2016
- K130394 Cadd -Solis Ambulatory Infusion Pump, Version 3.0cites it directly · 2013
- K140783 Halo Ambulatory Infusion Systemcites it directly · 2014
Most influential descendants
Showing 5 of 7 · See all- K130394Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 2013 · cites it directly4descendants
- K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion…Smiths Medical Ads, Inc. · 2017 · 2 generations on3descendants
- K232793Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…Zevex, Inc. · 2024 · cites it directly1descendant
- K140783Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · cites it directly1descendant
- K242660Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…Zevex, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960826 | Cadd-Prizm Model 6100 Pump | Sims Deltec, Inc. | 1996 | 1 |
| 0 (this device) | K111275 | Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety… | Smiths Medical Asd, Inc. | 2013 | — |
| +1 | K130394 | Cadd -Solis Ambulatory Infusion Pump, Version 3.0 | Smiths Medical Asd, Inc. | 2013 | Class I |
| +2 | K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis… | Smiths Medical Ads, Inc. | 2017 | Class I |
| +1 | K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software… | Zevex, Inc. | 2024 | — |
| +1 | K140783 | Halo Ambulatory Infusion System | Zyno Medical, LLC | 2014 | Class I |
| +2 | K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software… | Zevex, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 1 |
| 2014 | 1 | 1 |
| 2016 | 1 | 1 |
| 2017 | 1 | 1 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072144 | Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software -…Summary page 1…ystem Proprietary Name: CADD®-Solis VIP Ambulatory Infusion Pump CADDTM-Solis Medication Safety Software Predicate Devices: K072 144, CADDO-Solis Ambulatory Infusion Pump K960826, CADD-Prizm® VIP Ambulatory Infusion Pump… | 2008 |
| * | K960826 | Cadd-Prizm Model 6100 PumpSummary page 1…CADDTM-Solis Medication Safety Software Predicate Devices: K072 144, CADDO-Solis Ambulatory Infusion Pump K960826, CADD-Prizm® VIP Ambulatory Infusion Pump K082783, CADD TM -Solis Medication Safety Software-Point of… | 1996 |
| * | K082783 | Cadd -Solis Medication Safety Software: Administrator and Point-of-CareSummary page 1…dicate Devices: K072 144, CADDO-Solis Ambulatory Infusion Pump K960826, CADD-Prizm® VIP Ambulatory Infusion Pump K082783, CADD TM -Solis Medication Safety Software-Point of Care K072 144, CADD TM -Solis Medication Safety So… | 2008 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130394 | Cadd -Solis Ambulatory Infusion Pump, Version 3.0 Class I | 2013 | 4 |
| K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin… | 2024 | 1 |
| K140783 | Halo Ambulatory Infusion System Class I | 2014 | 1 |
| K153193 | Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion… Class I | 2016 | 0 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 10, 2025 | Class I | Z-1682-2025 | Under Investigation by firm | There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. |
| Apr 10, 2025 | Class I | Z-1668-2025 | Labeling design | Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death. |
| Jul 16, 2024 | Class I | Z-0222-2025 | Component design/selection | Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery pack case. If this… |
| Jun 26, 2024 | Class II | Z-0466-2025 | Device Design | The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug. |
| Feb 27, 2024 | Class I | Z-2421-2024 | Software Manufacturing/Software Deployment | The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion. |
| Mar 24, 2020 | Class I | Z-0107-2022 | Component change control | Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recognized by the pump and may not alarm to… |
The 5 latest of 6 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K072144Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - AdministratorSmiths Medical MD, Inc. · 2008 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 12 Class I recalls
- K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA…Zyno Medical, LLC · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 13 Class I recalls
- K130394Cadd -Solis Ambulatory Infusion Pump, Version 3.0Smiths Medical Asd, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K140783Halo Ambulatory Infusion SystemZyno Medical, LLC · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110…Smiths Medical Ads, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 15 Class I recalls
What does this lineage say?
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The CADD-Solis VIP Ambulatory Infusion Pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion. PCA (patient-controlled analgesia) delivery is used for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both, such as patient-controlled analgesia. Continuous delivery allows the infusion of drug/fluid at a constant…
Read the full statement (213 words)
The CADD-Solis VIP Ambulatory Infusion Pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
PCA (patient-controlled analgesia) delivery is used for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both, such as patient-controlled analgesia.
Continuous delivery allows the infusion of drug/fluid at a constant, programmed rate.
Intermittent delivery allows the infusion of a specific volume of drug/fluid at a regular, programmed interval.
Step delivery allows an incremental increase in infusion rate to a specified maximum infusion rate for a specified total infusion volume.
Taper delivery allows a plateau rate of infusion with the option of tapering at the beginning and/or end and has a programmable KVO rate at the end of the infusion.
The CADD-Solis Medication Safety Software - Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump or CADD-Prizm PCS II Ambulatory Infusion Pump (software revision H or higher).
The CADD-Solis Medication Safety Software - Point of Care allows use of a computer to send therapy-based protocols developed by the CADD-Solis Medication Safety Software - Administrator to the CADD-Solis Ambulatory Infusion Pump and CADD-Prizm PCS II Ambulatory Infusion Pump (software revision H or higher).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111275: Cadd Solis Vip Ambulatory Infusion Pump and Cadd Solis Medication Safety Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111275
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026