510(k) · Cleared
Recalled · Class I · 2024Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set
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 Nov 1, 2017 as substantially equivalent to K972135 (P/L Biomedical, 1997) and 3 other predicates after a 391-day review. Its family tree reaches back 3 generations to 1997. 2 of the 11 devices in its family, counting itself, have a Class I recall. It has been recalled 5 times, including 3 Class I recalls.
- Decided
- Nov 1, 2017
- Review
- 391 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 5 (3 Class I)
- Predicates
- 4
Its longest line of descent runs back 3 generations to K972135 (1997). 10 ancestors in all. No later device cites it as a predicate yet. 2 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK972135 Maersk Medical Pureline Comfort Subcutaneous Infusion SetP/L Biomedical · 1997 · Recalled
- 2 generations backK032854 Unomedical Monica Infusion SetUnomedical A/S · 2003 · Recalled
- 1 generation backK051264 Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott…Unomedical A/S · 2005 · Recalled
- This deviceK162812 Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort…Unomedical A/S · 2017
Class I recalls in this family
- K011071 Paradigm Quick-Set Infusion Set2 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972135 | Maersk Medical Pureline Comfort Subcutaneous Infusion Set | P/L Biomedical | 1997 | 16 |
| −2 | K032854 | Unomedical Monica Infusion Set | Unomedical A/S | 2003 | 1 |
| −1 | K051264 | Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion Pumps | Unomedical A/S | 2005 | 1 |
| 0 (this device) | K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short… | Unomedical A/S | 2017 | — |
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 |
| 2012 | 1 | 0 |
| 2016 | 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.
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 |
|---|---|---|---|
| * | K972135 | Maersk Medical Pureline Comfort Subcutaneous Infusion SetSummary page 7…l Equivalence The Comfort™ subcutaneous infusion Sets are substantially equivalent to the Subcutaneous Infusion Sets cleared under the following 510(k)s: K972135 – Maersk Medical Pureline Comfort Subcutaneous Infusion Set K051264 – Abbott Comfort™ Subcutaneous Infusion Set K120872 – Asante… | 1997 |
| * | K051264 | Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion PumpsSummary page 7…s are substantially equivalent to the Subcutaneous Infusion Sets cleared under the following 510(k)s: K972135 – Maersk Medical Pureline Comfort Subcutaneous Infusion Set K051264 – Abbott Comfort™ Subcutaneous Infusion Set K120872 – Asante Comfort™ Subcutaneous Infusion Set K160648 – Medtronic Silhouette® P… | 2005 |
| * | K120872 | Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl…Summary page 7…nfusion Sets cleared under the following 510(k)s: K972135 – Maersk Medical Pureline Comfort Subcutaneous Infusion Set K051264 – Abbott Comfort™ Subcutaneous Infusion Set K120872 – Asante Comfort™ Subcutaneous Infusion Set K160648 – Medtronic Silhouette® Paradigm Infusion Set 7.8 Predicate Devices The de… | 2012 |
| * | K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Summary page 7…72135 – Maersk Medical Pureline Comfort Subcutaneous Infusion Set K051264 – Abbott Comfort™ Subcutaneous Infusion Set K120872 – Asante Comfort™ Subcutaneous Infusion Set K160648 – Medtronic Silhouette® Paradigm Infusion Set 7.8 Predicate Devices The devices that serve as predicates for each of the subje… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 23, 2024 | Class II | Z-3186-2024 | Process change control | Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) branded "Trusteel Infusion Set". |
| Mar 5, 2024 | Class II | Z-1544-2024 | Device Design | Specific lots of Neria Soft Infusion Sets, which have been shipped into the US Market, have been shipped with the incorrect Instruction for Use (IFU) within the final pack. The IFU included is the IFU registered for the Rest of World… |
| Oct 11, 2023 | Class I | Z-0234-2024 | Process change control | The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin… |
| Oct 11, 2023 | Class I | Z-0232-2024 | Process change control | The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin… |
| Oct 11, 2023 | Class I | Z-0233-2024 | Process change control | The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the 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 · 2 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- 8 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- 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. 2017, 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?
The Unomedical Comfort™ Subcutaneous Infusion Set and Unomedical Comfort Short™ Subcutaneous Infusion Set are indicated for subcutaneous infusion of insulin administered by an external pump. The Unomedical Neria Soft Subcutaneous Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump. The Medtronic Silhouette® Subcutaneous (Luer Lock) Infusion Set is indicated for subcutaneous infusion of insulin from and…
Read the full statement (165 words)
The Unomedical Comfort™ Subcutaneous Infusion Set and Unomedical Comfort Short™ Subcutaneous Infusion Set are indicated for subcutaneous infusion of insulin administered by an external pump.
The Unomedical Neria Soft Subcutaneous Infusion Set is indicated for subcutaneous infusion of medication administered by an external pump.
The Medtronic Silhouette® Subcutaneous (Luer Lock) Infusion Set is indicated for subcutaneous infusion of insulin from and infusion pump.
The Medtronic Silhouette Paradigm® Subcutaneous Infusion Set is indicated for use with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment.
The Roche Accu-Chek Tender™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered with microdosage insulin pumps.
The Asante Comfort™ Subcutaneous Infusion Set is indicated for subcutaneous infusion of insulin administered by the Snap™ Insulin Pump System.
The Abbott Comfort™ Subcutaneous Infusion Set is indicated for infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir of a compatible Abbott pump.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162812: Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162812
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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