510(k) · Cleared
Recalled · Class II · 2017MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unomedical A/S · FPA Set, Administration, Intravascular
Cleared on Aug 10, 2016 as substantially equivalent to K011071 (Maersk Medical A/S, 2001) and 3 other predicates after a 156-day review. Its family tree reaches back 2 generations to 1997. 2 of the 9 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Aug 10, 2016
- Review
- 156 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 2 generations to K972135 (1997). 7 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK972135 Maersk Medical Pureline Comfort Subcutaneous Infusion SetP/L Biomedical · 1997 · Recalled
- 1 generation backK032854 Unomedical Monica Infusion SetUnomedical A/S · 2003 · Recalled
- This deviceK160648 MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S · 2016
- Descendant · cites it directly · 0 of its ownK162812 Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort…Unomedical A/S · 2017 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous…Unomedical A/S · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972135 | Maersk Medical Pureline Comfort Subcutaneous Infusion Set | P/L Biomedical | 1997 | 16 |
| −1 | K032854 | Unomedical Monica Infusion Set | Unomedical A/S | 2003 | 1 |
| 0 (this device) | K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® | Unomedical A/S | 2016 | — |
| +1 | K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short… | Unomedical A/S | 2017 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 1 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 1 |
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.
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? (4)
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 |
|---|---|---|---|
| * | K011071 | Paradigm Quick-Set Infusion SetSummary page 4…tial Equivalence The subject devices are substantially equivalent to the Subcutaneous Insulin Infusion Sets cleared under the following 510(k)s: 5.1 K011071– Medtronic Quick-Set® Paradigm® Subcutaneous Insulin Infusion Set 5.2 K041545 – Contact Detach (Marketed as… | 2001 |
| * | K041545 | Contact DetachSummary page 4…Infusion Sets cleared under the following 510(k)s: 5.1 K011071– Medtronic Quick-Set® Paradigm® Subcutaneous Insulin Infusion Set 5.2 K041545 – Contact Detach (Marketed as Medtronic Sure-T® Paradigm® Subcutaneous Insulin Infusion Set) 5.3 K002138 Me… | 2004 |
| * | K002138 | Paradigm Silhouette, Models MMT-377, 378, 379, 380Summary page 4…Insulin Infusion Set 5.2 K041545 – Contact Detach (Marketed as Medtronic Sure-T® Paradigm® Subcutaneous Insulin Infusion Set) 5.3 K002138 Medtronic Silhouette® Paradigm® Subcutaneous Insulin Infusion Set 5.4 K032854 – Unomedical Monica Infusion… | 2000 |
| * | K032854 | Unomedical Monica Infusion SetSummary page 4…Paradigm® Subcutaneous Insulin Infusion Set) 5.3 K002138 Medtronic Silhouette® Paradigm® Subcutaneous Insulin Infusion Set 5.4 K032854 – Unomedical Monica Infusion Set – (Marketed as Medtronic Mio® Subcutaneous Infusion Insulin Set)… | 2003 |
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 |
|---|---|---|---|
| K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous… Class I | 2017 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 10, 2017 | Class II | Z-0109-2018 | Component design/selection | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. |
| Sep 10, 2017 | Class II | Z-0110-2018 | Component design/selection | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. |
| Sep 10, 2017 | Class II | Z-0107-2018 | Component design/selection | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. |
| Sep 10, 2017 | Class II | Z-0108-2018 | Component design/selection | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. |
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 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
- K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical…Unomedical A/S · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 12.8 years on median.
- 5 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K162812 (Unomedical A/S, 2017) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K011071.
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?
These sets are intended to be used with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160648: MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160648
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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