510(k) · Cleared
Recalled · Class I · 2013Paradigm Quick-Set Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maersk Medical A/S · FPA Set, Administration, Intravascular
Cleared on Jun 7, 2001 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 22 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Jun 7, 2001
- Review
- 59 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 2 (1 Class I)
- Predicates
- 0
21 later devices descend from it, 6 citing it directly. 2 of the 22 devices in this family, counting this one, have a Class I recall.
- This deviceK011071 Paradigm Quick-Set Infusion SetMaersk Medical A/S · 2001
- Descendant · cites it directly · 14 of its ownK032854 Unomedical Monica Infusion SetUnomedical A/S · 2003 · Recalled
- Descendant · 2 generations on · 3 of its ownK173879 MiniMed Mio Advance infusion setUnomedical A/S · 2018
- Descendant · cites it directly · 3 of its ownK150059 BD FlowSmart SetBecton, Dickinson Company · 2015
- Descendant · 2 generations on · 2 of its ownK153257 BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company · 2015
- Descendant · cites it directly · 2 of its ownK061374 Intuition Infusion SetsUnomedical A/S · 2006
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K162812 Unomedical Comfort Subcutaneous Infusion Set…2 generations on · 2017
Most influential descendants
Showing 5 of 21 · See all- K032854Unomedical Monica Infusion SetUnomedical A/S · 2003 · cites it directly14descendants
- K173879MiniMed Mio Advance infusion setUnomedical A/S · 2018 · 2 generations on3descendants
- K150059BD FlowSmart SetBecton, Dickinson Company · 2015 · cites it directly3descendants
- K153257BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company · 2015 · 2 generations on2descendants
- K061374Intuition Infusion SetsUnomedical A/S · 2006 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011071 | Paradigm Quick-Set Infusion Set | Maersk Medical A/S | 2001 | — |
| +1 | K032854 | Unomedical Monica Infusion Set | Unomedical A/S | 2003 | 1 |
| +2 | K173879 | MiniMed Mio Advance infusion set | Unomedical A/S | 2018 | — |
| +1 | K150059 | BD FlowSmart Set | Becton, Dickinson Company | 2015 | — |
| +2 | K153257 | BD FlowSmart Set, MiniMed Pro-Set | Becton, Dickinson and Company | 2015 | — |
| +1 | K061374 | Intuition Infusion Sets | Unomedical A/S | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 1 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (21)
See all 216 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032854 | Unomedical Monica Infusion Set | 2003 | 14 |
| K150059 | BD FlowSmart Set | 2015 | 3 |
| K061374 | Intuition Infusion Sets | 2006 | 2 |
| K041545 | Contact Detach | 2004 | 2 |
| K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® | 2016 | 1 |
| K070430 | Paradigm Quick-Set II and Quick-Set II Subcutaneous Infusion Sets | 2007 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 7, 2013 | Class I | Z-1668-2013 | Device Design | Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the… |
| Jun 29, 2009 | Not classified | Z-1705-2009 | Process control | Approximately 2% of the infusion sets in the affected lots may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the syringe compartment with the surrounding atmosphere. If the vent does not… |
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.
- K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical…Unomedical A/S · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- Of its descendants, K032854 (Unomedical A/S, 2003) has gone furthest, with 14 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) | — |
https://510kreport.com/device/K011071 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011071: Paradigm Quick-Set Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011071
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026