510(k) · Cleared
ClearedSteadiSet infusion set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tandem Diabetes Care · FPA Set, Administration, Intravascular
Cleared on Aug 6, 2025 as substantially equivalent to K242692 (Capillary Biomedical, LLC, 2025) after a 50-day review. Its family tree reaches back 4 generations to 1997. 1 of the 9 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 6, 2025
- Review
- 50 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K972135 (1997). 8 ancestors in all. No later device cites it as a predicate yet. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK972135 Maersk Medical Pureline Comfort Subcutaneous Infusion SetP/L Biomedical · 1997 · Recalled
- 3 generations backK032854 Unomedical Monica Infusion SetUnomedical A/S · 2003 · Recalled
- 2 generations backK061374 Intuition Infusion SetsUnomedical A/S · 2006
- 1 generation backK242692 SteadiSet Infusion SetCapillary Biomedical, LLC · 2025
- This deviceK251854 SteadiSet infusion setTandem Diabetes Care · 2025
Class I recalls in this family
- K011071 Paradigm Quick-Set Infusion Set3 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972135 | Maersk Medical Pureline Comfort Subcutaneous Infusion Set | P/L Biomedical | 1997 | 16 |
| −3 | K032854 | Unomedical Monica Infusion Set | Unomedical A/S | 2003 | 1 |
| −2 | K061374 | Intuition Infusion Sets | Unomedical A/S | 2006 | — |
| −1 | K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | 2025 | — |
| 0 (this device) | K251854 | SteadiSet infusion set | Tandem Diabetes Care | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 2 | 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.
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 |
|---|---|---|---|
| * | K242692 | SteadiSet Infusion SetSummary page 5…Regulatory Class Class II Product Code FPA III. PREDICATE DEVICE Predicate Device K242692, SteadiSet infusion set IV. DEVICE BRIEF DESCRIPTION The subject device, SteadiSet infusion set, is a sterile, n… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K011071Paradigm Quick-Set Infusion SetMaersk Medical A/S · 2001 · 3 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 3 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 SteadiSet infusion set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251854: SteadiSet 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/K251854
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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