510(k) · Cleared
Recalled · Class II · 2014Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl Infusion Pumps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unomedical A/S Infusion Devices · FPA Set, Administration, Intravascular
Cleared on Apr 20, 2012 as substantially equivalent to K032854 (Unomedical A/S, 2003) after a 29-day review. Its family tree reaches back 2 generations to 1997. 2 of the 7 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 10 times.
- Decided
- Apr 20, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 10
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972135 (1997). 5 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 7 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 deviceK120872 Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use…Unomedical A/S Infusion Devices · 2012
- 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) | K120872 | Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with… | Unomedical A/S Infusion Devices | 2012 | — |
| +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 |
| 2001 | 1 | 1 |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K0972135 | Unomedical Comfort Number could not be read | |
| * | K032854 | Unomedical Monica Infusion SetSummary page 1…nomedical Comfort TM (K9721 35) and asante consetTM infusion sets for use with the Asante PearTM Pump are substantially equivalent to the Unomedical lnsetTM (K032854) infusion sets. 8.6 General Description 8.6.1 Asante comfortTM The asante comfortTM Subcutaneo… | 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 |
|---|---|---|---|---|
| Nov 7, 2014 | Class II | Z-0357-2017 | Device Design | Tubing detachment |
| Nov 7, 2014 | Class II | Z-0358-2017 | Device Design | Tubing detachment |
| Nov 7, 2014 | Class II | Z-0355-2017 | Device Design | Tubing detachment |
| Nov 19, 2013 | Class II | Z-0595-2014 | Device Design | Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. |
| Nov 19, 2013 | Class II | Z-0594-2014 | Device Design | Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. |
| Nov 19, 2013 | Class II | Z-0596-2014 | Device Design | Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. |
| Nov 19, 2013 | Class II | Z-0597-2014 | Device Design | Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. |
| Nov 19, 2013 | Class II | Z-0599-2014 | Device Design | Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. |
| Nov 19, 2013 | Class II | Z-0600-2014 | Device Design | Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. |
| Nov 19, 2013 | Class II | Z-0601-2014 | Device Design | Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. |
The 5 latest of 10 recalls; the web page lists all.
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 · 2 generations back · ◆ 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 15 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
- 3 of the 5 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.
- 7 other devices also cite its predicate K032854.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 infusion sets are indicated for the subcutaneous infusion of medication from an external Infusion Pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120872 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120872: Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl Infusion Pumps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120872
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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