510(k) · Cleared
Recalled · Class II · 2014Paradigm Silhouette, Models MMT-377, 378, 379, 380
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 Aug 29, 2000 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 29, 2000
- Review
- 43 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 2 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK002138 Paradigm Silhouette, Models MMT-377, 378, 379, 380Maersk Medical A/S · 2000
- Descendant · cites it directly · 1 of its ownK160648 MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK162812 Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort…Unomedical A/S · 2017 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK032484 Medtronic Minimed Paradigm Countach Infusion Set, Model MMT 310Medtronic Minimed · 2003
Class I recalls in this family
- K162812 Unomedical Comfort Subcutaneous Infusion Set…2 generations on · 2017
Most influential descendants
Showing 3 of 3 · See all- K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S · 2016 · cites it directly1descendant
- K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous…Unomedical A/S · 2017 · 2 generations on0descendants
- K032484Medtronic Minimed Paradigm Countach Infusion Set, Model MMT 310Medtronic Minimed · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002138 | Paradigm Silhouette, Models MMT-377, 378, 379, 380 | Maersk Medical A/S | 2000 | — |
| +1 | K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® | Unomedical A/S | 2016 | 4 |
| +2 | K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short… | Unomedical A/S | 2017 | Class I |
| +1 | K032484 | Medtronic Minimed Paradigm Countach Infusion Set, Model MMT 310 | Medtronic Minimed | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 1 |
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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2014 | Class II | Z-0359-2017 | Device Design | Tubing detachment |
| Nov 4, 2014 | Class II | Z-0524-2015 | Process change control | Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted insulin delivery and the pump will not alarm to notify your patient. This can lead to… |
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, K160648 (Unomedical A/S, 2016) has gone furthest, with 1 descendant 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/K002138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002138: Paradigm Silhouette, Models MMT-377, 378, 379, 380.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002138
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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