510(k) · Cleared
Recalled · 2011Talon Infusion Set, Model IP XXXX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · FPA Set, Administration, Intravascular
Cleared on Apr 12, 2004 after a 181-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 12, 2004
- Review
- 181 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 3
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK033290 Talon Infusion Set, Model IP XXXXIcu Medical, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK130468 Orbit Infusion SetYpsomed AG · 2013
- Descendant · 2 generations on · 3 of its ownK150059 BD FlowSmart SetBecton, Dickinson Company · 2015
- Descendant · 3 generations on · 2 of its ownK153257 BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company · 2015
- Descendant · 4 generations on · 1 of its ownK160651 BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company · 2016 · Recalled
- Descendant · 5 generations on · 0 of its ownK181718 BD FlowSmart Set/MiniMed Pro-SetBecton, Dickinson and Company · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K130468Orbit Infusion SetYpsomed AG · 2013 · cites it directly5descendants
- K150059BD FlowSmart SetBecton, Dickinson Company · 2015 · 2 generations on3descendants
- K153257BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company · 2015 · 3 generations on2descendants
- K160651BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company · 2016 · 4 generations on1descendant
- K181718BD FlowSmart Set/MiniMed Pro-SetBecton, Dickinson and Company · 2018 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033290 | Talon Infusion Set, Model IP XXXX | Icu Medical, Inc. | 2004 | — |
| +1 | K130468 | Orbit Infusion Set | Ypsomed AG | 2013 | — |
| +2 | K150059 | BD FlowSmart Set | Becton, Dickinson Company | 2015 | — |
| +3 | K153257 | BD FlowSmart Set, MiniMed Pro-Set | Becton, Dickinson and Company | 2015 | — |
| +4 | K160651 | BD FlowSmart Set, MiniMed Pro-Set | Becton, Dickinson and Company | 2016 | 2 |
| +5 | K181718 | BD FlowSmart Set/MiniMed Pro-Set | Becton, Dickinson and Company | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 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 FPA? 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? (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 |
|---|---|---|---|
| * | — | Glucopro Infusion Set Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130468 | Orbit Infusion Set | 2013 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2011 | Not classified | Z-0592-2012 | Pending | The recall was initiated because ICU Medical Inc. has become aware of the market recall of the Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various… |
| Mar 1, 2011 | Not classified | Z-0593-2012 | Pending | The recall was initiated because ICU Medical Inc. has become aware of the market recall of the Triad Group's alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad in the United States and marketed under various… |
| Sep 26, 2006 | Not classified | Z-1166-2007 | Other | The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K130468 (Ypsomed AG, 2013) has gone furthest, with 5 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 Talon insulin pump infusion set is an administration infusion set intended to be used for subcutaneous infusion of medicine solutions, such as insulin, from an external infusion pump
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033290 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033290: Talon Infusion Set, Model IP XXXX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033290
Report an extraction error
Are you the manufacturer?
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