510(k) · Cleared
ClearedHumaPen Luxura
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eli Lilly and Company · FMF Syringe, Piston
Cleared on Jun 5, 2015 as substantially equivalent to K100988 (Eli Lilly and Company, 2010) after a 270-day review. Its family tree reaches back 4 generations to 1990. 3 later devices descend from it.
- Decided
- Jun 5, 2015
- Review
- 270 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K895890 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK895890 AutopenUlster Scientific, Inc. · 1990
- 3 generations backK983974 Owen Mumford 3ML AutopenOwen Mumford USA, Inc. · 1998 · Recalled
- 2 generations backK063151 Humapen Luxura HDEli Lilly and Co. · 2007
- 1 generation backK100988 Humapen Luxura HDEli Lilly and Company · 2010
- This deviceK142518 HumaPen LuxuraEli Lilly and Company · 2015
- Descendant · cites it directly · 1 of its ownK160668 HumaPen SavvioEli Lilly and Company, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK250262 GO-PEN®Go-Pen Aps · 2025
- Descendant · cites it directly · 0 of its ownK151686 HumanPen Ergo IIEli Lilly and Company, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895890 | Autopen | Ulster Scientific, Inc. | 1990 | — |
| −3 | K983974 | Owen Mumford 3ML Autopen | Owen Mumford USA, Inc. | 1998 | 1 |
| −2 | K063151 | Humapen Luxura HD | Eli Lilly and Co. | 2007 | — |
| −1 | K100988 | Humapen Luxura HD | Eli Lilly and Company | 2010 | — |
| 0 (this device) | K142518 | HumaPen Luxura | Eli Lilly and Company | 2015 | — |
| +1 | K160668 | HumaPen Savvio | Eli Lilly and Company, Inc. | 2016 | — |
| +2 | K250262 | GO-PEN® | Go-Pen Aps | 2025 | — |
| +1 | K151686 | HumanPen Ergo II | Eli Lilly and Company, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 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.
Planning a device in FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 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 |
|---|---|---|---|
| * | K100988 | Humapen Luxura HDSummary page 4…: FMF Class: II 807.92(a)(3) Predicate Device 510(k) Number Device Name Submitter Name K100988 HumaPen Luxura HD Eli Lilly and Company 807.92(a)(4) De… | 2010 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K160668 (Eli Lilly and Company, Inc., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
HumaPen Luxura is a reusable insulin Pen intended for the self-injection of HUMALOG® (insulin lispro for injection) available in 3 mL Cartridges using disposable Pen Needles (sold separately).
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/K142518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142518: HumaPen Luxura.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142518
Report an extraction error
Are you the manufacturer?
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