510(k) · Cleared
Recalled · 2011Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion Pumps
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 Sep 1, 2005 as substantially equivalent to K972135 (P/L Biomedical, 1997) and 1 other predicate after a 108-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 once.
- Decided
- Sep 1, 2005
- Review
- 108 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 1
- 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 deviceK051264 Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott…Unomedical A/S · 2005
- 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) | K051264 | Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion Pumps | Unomedical A/S | 2005 | — |
| +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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972135 | Maersk Medical Pureline Comfort Subcutaneous Infusion SetSummary page 1…tial Equivalence The Comfort~m and lnsetTM Subcutaneous Infusion Sets for use with the Abbott Pump are substantially equivalent to the Unomnedical ComfortTM'(K972135) and Inset® (K032854) sets. 8.6 Technological Characteristics The ComfortTm and Inset 1'mSubcutaneous Infusion… | 1997 |
| * | K032854 | Unomedical Monica Infusion SetSummary page 1…Comfort~m and lnsetTM Subcutaneous Infusion Sets for use with the Abbott Pump are substantially equivalent to the Unomnedical ComfortTM'(K972135) and Inset® (K032854) sets. 8.6 Technological Characteristics The ComfortTm and Inset 1'mSubcutaneous Infusion Sets for use with the Abbo… | 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 |
|---|---|---|---|---|
| May 16, 2011 | Not classified | Z-0202-2012 | Employee error | The consignee received four (4) boxes of mio infusion sets (MMT-921) that were shipped to them in error. These infusion sets were shipped in a package that included a MiniMed Paradigm REAL-TIME Insulin Pump among other items. The mio… |
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 8 years and passes through 2 companies; a new generation was cleared every 6.1 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 K972135.
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?
These sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051264: Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion Pumps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051264
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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