510(k) · Cleared
ClearedMaersk Medical Contour 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 25, 1999 after a 32-day review. The FDA summary names its predicate without a number. 1 of the 17 devices in its family, counting itself, has a Class I recall. 16 later devices descend from it.
- Decided
- Jun 25, 1999
- Review
- 32 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- This deviceK991759 Maersk Medical Contour Infusion SetMaersk Medical A/S · 1999
- 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 · 2 generations on · 2 of its ownK061374 Intuition Infusion SetsUnomedical A/S · 2006
- Descendant · 3 generations on · 1 of its ownK243841 Sparta Infusion Set for InsulinDeka Research and Development · 2025
- Descendant · 3 generations on · 1 of its ownK242692 SteadiSet Infusion SetCapillary Biomedical, LLC · 2025
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K162812 Unomedical Comfort Subcutaneous Infusion Set…3 generations on · 2017
Most influential descendants
Showing 5 of 16 · See all- K032854Unomedical Monica Infusion SetUnomedical A/S · 2003 · cites it directly14descendants
- K173879MiniMed Mio Advance infusion setUnomedical A/S · 2018 · 2 generations on3descendants
- K061374Intuition Infusion SetsUnomedical A/S · 2006 · 2 generations on2descendants
- K243841Sparta Infusion Set for InsulinDeka Research and Development · 2025 · 3 generations on1descendant
- K242692SteadiSet Infusion SetCapillary Biomedical, LLC · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991759 | Maersk Medical Contour Infusion Set | Maersk Medical A/S | 1999 | — |
| +1 | K032854 | Unomedical Monica Infusion Set | Unomedical A/S | 2003 | 1 |
| +2 | K173879 | MiniMed Mio Advance infusion set | Unomedical A/S | 2018 | — |
| +2 | K061374 | Intuition Infusion Sets | Unomedical A/S | 2006 | — |
| +3 | K243841 | Sparta Infusion Set for Insulin | Deka Research and Development | 2025 | — |
| +3 | K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Maersk Medical Comfort™ Infusion Set Named without a submission number |
What descends from it? (16)
See all 163 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)
No FDA recall names this device.
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 · 3 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) | — |
What is it indicated for?
The Maersk Medical Contour infusion set is indicated for subcutaneous delivery of appropriately labeled fluids or solutions from an external infusion pump.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991759 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991759: Maersk Medical Contour Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991759
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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