510(k) · Cleared
Recalled · Class I · 2025Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical MD, Inc. · FPA Set, Administration, Intravascular
Cleared on May 19, 2004 after a 70-day review. The FDA summary names its predicate without a number. 4 of the 8 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 6 times, including a Class I recall.
- Decided
- May 19, 2004
- Review
- 70 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 6 (1 Class I)
- Predicates
- 0
7 later devices descend from it, 3 citing it directly. 4 of the 8 devices in this family, counting this one, have a Class I recall.
- This deviceK040636 Cadd Administration Set with Flow Stop, Medication Cassette…Smiths Medical MD, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK170982 CADD®- Solis Ambulatory Infusion Pump with Wireless Communication…Smiths Medical Ads, Inc. · 2017 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK081156 Cadd Medication Cassette ReservoirSmiths Medical MD, Inc. · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK232793 Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES)…Zevex, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK162219 CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · Recalled (Class I)
- Descendant · 3 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
Most influential descendants
Showing 5 of 7 · See all- K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion…Smiths Medical Ads, Inc. · 2017 · cites it directly3descendants
- K081156Cadd Medication Cassette ReservoirSmiths Medical MD, Inc. · 2008 · cites it directly2descendants
- K232793Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…Zevex, Inc. · 2024 · 2 generations on1descendant
- K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · cites it directly1descendant
- K242660Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin…Zevex, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040636 | Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with… | Smiths Medical MD, Inc. | 2004 | — |
| +1 | K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis… | Smiths Medical Ads, Inc. | 2017 | Class I |
| +1 | K081156 | Cadd Medication Cassette Reservoir | Smiths Medical MD, Inc. | 2008 | Class I |
| +2 | K232793 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software… | Zevex, Inc. | 2024 | — |
| +1 | K162219 | CADD® Infusion Disposables Portfolio with NRFit™ connectors | Smiths Medical Asd, Inc. | 2017 | Class I |
| +3 | K242660 | Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software… | Zevex, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2017 | 2 | 2 |
| 2021 | 1 | 0 |
| 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.
4 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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® Medication Cassette Reservoir Named without a submission number | |
| * | — | CADD® Administration Set Named without a submission number |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2025 | Class II | Z-2522-2025 | Under Investigation by firm | Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter. |
| Dec 9, 2022 | Class I | Z-0963-2023 | Under Investigation by firm | There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms |
| Mar 17, 2017 | Class II | Z-1767-2017 | Packaging process control | Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD¿ Administration Sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. Although the… |
| Apr 22, 2016 | Class II | Z-1831-2016 | Nonconforming Material/Component | Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop. |
| Feb 2, 2015 | Class II | Z-1286-2015 | Under Investigation by firm | Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs ( Cassette ). Some Cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has received no… |
| Dec 14, 2007 | Not classified | Z-0879-2008 | Process control | Leakage associated with the CADD Medication Cassette Reservoirs for use with the CADD Ambulatory Infusion Pumps |
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.
- K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110…Smiths Medical Ads, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 15 Class I recalls
- K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsSmiths Medical Asd, Inc. · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K081156Cadd Medication Cassette ReservoirSmiths Medical MD, Inc. · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K170982 (Smiths Medical Ads, Inc., 2017) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The CADD® Medication Cassette Reservoir with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids.
The CADD® Administration Set with Flow Stop is designed for use with the CADD® pumps (except CADD-Microo and CADD-TPN ) for delivery of medications and fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040636: Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040636
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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