510(k) · Cleared
Recalled · 2008Cadd-MS 3 Ambulatory Infusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical MD, Inc. · FRN Pump, Infusion
Cleared on Nov 17, 2005 after a 156-day review. The FDA summary names its predicate without a number. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 17, 2005
- Review
- 156 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 2
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK051568 Cadd-MS 3 Ambulatory Infusion PumpSmiths Medical MD, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK190182 Unity Subcutaneous Delivery System for RemodulinDEKA Research & Development · 2019
- Descendant · 2 generations on · 3 of its ownK191313 Unity Subcutaneous Infusion System for RemodulinDEKA Research & Development · 2020
- Descendant · 2 generations on · 2 of its ownK241736 Remunity 2.0 Pump for Remodulin (treprostinil) InjectionDeka Research and Development Corp. · 2025
- Descendant · 3 generations on · 1 of its ownK250357 RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionDeka Research & Development Corp. · 2025
- Descendant · 3 generations on · 1 of its ownK202690 Remunity Pump for Remodulin (treprostinil) InjectionDeka Research and Development · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K190182Unity Subcutaneous Delivery System for RemodulinDEKA Research & Development · 2019 · cites it directly7descendants
- K191313Unity Subcutaneous Infusion System for RemodulinDEKA Research & Development · 2020 · 2 generations on3descendants
- K241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionDeka Research and Development Corp. · 2025 · 2 generations on2descendants
- K250357RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionDeka Research & Development Corp. · 2025 · 3 generations on1descendant
- K202690Remunity Pump for Remodulin (treprostinil) InjectionDeka Research and Development · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051568 | Cadd-MS 3 Ambulatory Infusion Pump | Smiths Medical MD, Inc. | 2005 | — |
| +1 | K190182 | Unity Subcutaneous Delivery System for Remodulin | DEKA Research & Development | 2019 | — |
| +2 | K191313 | Unity Subcutaneous Infusion System for Remodulin | DEKA Research & Development | 2020 | — |
| +2 | K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | Deka Research and Development Corp. | 2025 | — |
| +3 | K250357 | RemunityPRO™ Pump for Remodulin® (treprostinil) Injection | Deka Research & Development Corp. | 2025 | — |
| +3 | K202690 | Remunity Pump for Remodulin (treprostinil) Injection | Deka Research and Development | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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.
Planning a device in FRN? 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? (1)
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 |
|---|---|---|---|
| * | — | CADD-Micro® Ambulatory Infusion Pump Named without a submission number |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 7, 2008 | Not classified | Z-1621-2008 | Component change control | Smiths Medical discovered an issue with a motor component in specific serial numbers of the CADD-MS 3 Ambulatory Infusion Pump. This issue affects motor operation and may cause an over-delivery of medication which could result in injury… |
| Feb 22, 2008 | Not classified | Z-1641-2008 | Labeling design | Smiths Medical has received reports that the device powers down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the pump may power down and a brief "chirp" will sound. This may occur if the user… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K190182 (DEKA Research & Development, 2019) has gone furthest, with 7 descendants of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
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-MS TM 3 Ambulatory Infusion Pump is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medication."
"The Smiths Medical MD, Inc, 3-ml Cartridge Reservoir is designed for use with the CADD-MS" 3 for delivering medication."
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051568: Cadd-MS 3 Ambulatory Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051568
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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