510(k) · Cleared
Recalled · Class II · 2017BD FlowSmart Set, MiniMed Pro-Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · FPA Set, Administration, Intravascular
Cleared on Apr 7, 2016 as substantially equivalent to K153257 (Becton, Dickinson and Company, 2015) after a 30-day review. Its family tree reaches back 4 generations to 2004. 1 of the 7 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 7, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K033290 (2004). 5 ancestors in all, the oldest K011071 (2001). 1 later device descends from it, 1 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK033290 Talon Infusion Set, Model IP XXXXIcu Medical, Inc. · 2004 · Recalled
- 3 generations backK130468 Orbit Infusion SetYpsomed AG · 2013
- 2 generations backK150059 BD FlowSmart SetBecton, Dickinson Company · 2015
- 1 generation backK153257 BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company · 2015
- This deviceK160651 BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company · 2016
- Descendant · cites it directly · 0 of its ownK181718 BD FlowSmart Set/MiniMed Pro-SetBecton, Dickinson and Company · 2018
Class I recalls in this family
- K011071 Paradigm Quick-Set Infusion Set3 generations back · 2001
Most influential descendants
Showing 1 of 1 · See all- K181718BD FlowSmart Set/MiniMed Pro-SetBecton, Dickinson and Company · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K033290 | Talon Infusion Set, Model IP XXXX | Icu Medical, Inc. | 2004 | 3 |
| −3 | K130468 | Orbit Infusion Set | Ypsomed AG | 2013 | — |
| −2 | K150059 | BD FlowSmart Set | Becton, Dickinson Company | 2015 | — |
| −1 | K153257 | BD FlowSmart Set, MiniMed Pro-Set | Becton, Dickinson and Company | 2015 | — |
| 0 (this device) | K160651 | BD FlowSmart Set, MiniMed Pro-Set | Becton, Dickinson and Company | 2016 | — |
| +1 | K181718 | BD FlowSmart Set/MiniMed Pro-Set | Becton, Dickinson and Company | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K153257 | BD FlowSmart Set, MiniMed Pro-SetSummary page 4…ascular administration set) Legally marketed predicate devices to which substantial equivalence is being claimed: K153257 – BD FlowSmart™ Set/MiniMed™ Pro-Set™ Device Description: The BD FlowSmart™/MiniMed™ Pro-Set™ infusion set is a subcutaneous… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181718 | BD FlowSmart Set/MiniMed Pro-Set | 2018 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 10, 2017 | Class II | Z-0111-2018 | Component design/selection | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. |
| Dec 23, 2016 | Class II | Z-1897-2017 | Device Design | Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked. |
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.
- K011071Paradigm Quick-Set Infusion SetMaersk Medical A/S · 2001 · 3 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K181718 (Becton, Dickinson and Company, 2018) has gone furthest, with 0 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. 2016, this device’s year, is highlighted.
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 BD FlowSmart™/MiniMed™ Pro-Set™ infusion set is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160651: BD FlowSmart Set, MiniMed Pro-Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160651
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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