510(k) · Cleared
ClearedGO-PEN®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Go-Pen Aps · FMF Syringe, Piston
Cleared on Apr 24, 2025 as substantially equivalent to K160668 (Eli Lilly and Company, Inc., 2016) after an 85-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Apr 24, 2025
- Review
- 85 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K895890 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK895890 AutopenUlster Scientific, Inc. · 1990
- 5 generations backK983974 Owen Mumford 3ML AutopenOwen Mumford USA, Inc. · 1998 · Recalled
- 4 generations backK063151 Humapen Luxura HDEli Lilly and Co. · 2007
- 3 generations backK100988 Humapen Luxura HDEli Lilly and Company · 2010
- 2 generations backK142518 HumaPen LuxuraEli Lilly and Company · 2015
- 1 generation backK160668 HumaPen SavvioEli Lilly and Company, Inc. · 2016
- This deviceK250262 GO-PEN®Go-Pen Aps · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K895890 | Autopen | Ulster Scientific, Inc. | 1990 | — |
| −5 | K983974 | Owen Mumford 3ML Autopen | Owen Mumford USA, Inc. | 1998 | 1 |
| −4 | K063151 | Humapen Luxura HD | Eli Lilly and Co. | 2007 | — |
| −3 | K100988 | Humapen Luxura HD | Eli Lilly and Company | 2010 | — |
| −2 | K142518 | HumaPen Luxura | Eli Lilly and Company | 2015 | — |
| −1 | K160668 | HumaPen Savvio | Eli Lilly and Company, Inc. | 2016 | — |
| 0 (this device) | K250262 | GO-PEN® | Go-Pen Aps | 2025 | — |
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 |
|---|---|---|---|
| * | K160668 | HumaPen SavvioSummary page 5…/Common Name: Insulin Pen Injector Classification: II Regulation: 21 CFR 880.5860 Regulation Name: Piston Syringe Product Code: FMF PREDICATE DEVICE(S) HumaPen Savvio, (K160668) DEVICE DESCRIPTION GO-PEN® is an assembly of a durable pen-shaped dosing unit with a special disposable sterile reservoir that… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 6 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
GO-PEN® is a reusable insulin pen intended for the self-injection of NovoLog® (U-100, insulin aspart for injection) available in 10 ml vials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250262: GO-PEN®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250262
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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