510(k) · Cleared
ClearedHumapen Luxura HD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eli Lilly and Co. · NSC Injector, Pen
Cleared on Jan 9, 2007 as substantially equivalent to K983974 (Owen Mumford USA, Inc., 1998) after an 85-day review. Its family tree reaches back 2 generations to 1990. 5 later devices descend from it.
- Decided
- Jan 9, 2007
- Review
- 85 days
- Class
- Class II
- Product code
- NSC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K895890 (1990). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK895890 AutopenUlster Scientific, Inc. · 1990
- 1 generation backK983974 Owen Mumford 3ML AutopenOwen Mumford USA, Inc. · 1998 · Recalled
- This deviceK063151 Humapen Luxura HDEli Lilly and Co. · 2007
- Descendant · cites it directly · 4 of its ownK100988 Humapen Luxura HDEli Lilly and Company · 2010
- Descendant · 2 generations on · 3 of its ownK142518 HumaPen LuxuraEli Lilly and Company · 2015
- Descendant · 3 generations on · 1 of its ownK160668 HumaPen SavvioEli Lilly and Company, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK250262 GO-PEN®Go-Pen Aps · 2025
- Descendant · 3 generations on · 0 of its ownK151686 HumanPen Ergo IIEli Lilly and Company, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K100988Humapen Luxura HDEli Lilly and Company · 2010 · cites it directly4descendants
- K142518HumaPen LuxuraEli Lilly and Company · 2015 · 2 generations on3descendants
- K160668HumaPen SavvioEli Lilly and Company, Inc. · 2016 · 3 generations on1descendant
- K250262GO-PEN®Go-Pen Aps · 2025 · 4 generations on0descendants
- K151686HumanPen Ergo IIEli Lilly and Company, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895890 | Autopen | Ulster Scientific, Inc. | 1990 | — |
| −1 | K983974 | Owen Mumford 3ML Autopen | Owen Mumford USA, Inc. | 1998 | 1 |
| 0 (this device) | K063151 | Humapen Luxura HD | Eli Lilly and Co. | 2007 | — |
| +1 | K100988 | Humapen Luxura HD | Eli Lilly and Company | 2010 | — |
| +2 | K142518 | HumaPen Luxura | Eli Lilly and Company | 2015 | — |
| +3 | K160668 | HumaPen Savvio | Eli Lilly and Company, Inc. | 2016 | — |
| +4 | K250262 | GO-PEN® | Go-Pen Aps | 2025 | — |
| +3 | K151686 | HumanPen Ergo II | Eli Lilly and Company, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 2 | 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 NSC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K983974 | Owen Mumford 3ML Autopen Our reading of the summary gave K983874, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Autopen®”. | 1998 |
| * | — | NovoPen® Junior Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100988 | Humapen Luxura HD | 2010 | 4 |
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 17 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K100988 (Eli Lilly and Company, 2010) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K983974.
How does its category compare?
All NSC devicesNSC Injector, Pen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NSC
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · NSC
Too few NSC 510(k)s in any year since 2007 to give a median.
Recalls per year · NSC
No recall names NSC since 2007.
Adverse event reports per year · NSC
7in 2025
MAUDE reports naming product code NSC, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 36 |
| 2010 | 0 | — | 0 | 105 |
| 2011 | 0 | — | 0 | 91 |
| 2012 | 0 | — | 0 | 46 |
| 2013 | 0 | — | 0 | 22 |
| 2014 | 0 | — | 0 | 34 |
| 2015 | 0 | — | 0 | 55 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 90 |
| 2020 | 0 | — | 0 | 34 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HumaPen Luxura HD is a reusable pen injector designed for use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 1 to 30 units in one-half (1/2) unit increments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063151: Humapen Luxura HD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063151
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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