510(k) · Cleared
ClearedNovopen 1.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novo Nordisk Pharmaceuticals, Inc. · FMF Syringe, Piston
Cleared on Apr 26, 1995 after a 358-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 26, 1995
- Review
- 358 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK942159 Novopen 1.5Novo Nordisk Pharmaceuticals, Inc. · 1995
- Descendant · cites it directly · 4 of its ownK982966 Disetronic PenDisetronic Medical Systems · 1998
- Descendant · 2 generations on · 2 of its ownK070100 Haselmeier PenHaselmeier Sarl · 2007
- Descendant · 2 generations on · 0 of its ownK083457 TactipenHaselmeier GmbH · 2009
- Descendant · 3 generations on · 0 of its ownK082616 Haselmeier Pen 8Haselmeier GmbH · 2008
- Descendant · 2 generations on · 0 of its ownK993666 Disetronic Pen P100Disetronic Medical Systems · 1999
Most influential descendants
Showing 5 of 5 · See all- K982966Disetronic PenDisetronic Medical Systems · 1998 · cites it directly4descendants
- K070100Haselmeier PenHaselmeier Sarl · 2007 · 2 generations on2descendants
- K083457TactipenHaselmeier GmbH · 2009 · 2 generations on0descendants
- K082616Haselmeier Pen 8Haselmeier GmbH · 2008 · 3 generations on0descendants
- K993666Disetronic Pen P100Disetronic Medical Systems · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942159 | Novopen 1.5 | Novo Nordisk Pharmaceuticals, Inc. | 1995 | — |
| +1 | K982966 | Disetronic Pen | Disetronic Medical Systems | 1998 | — |
| +2 | K070100 | Haselmeier Pen | Haselmeier Sarl | 2007 | — |
| +2 | K083457 | Tactipen | Haselmeier GmbH | 2009 | — |
| +3 | K082616 | Haselmeier Pen 8 | Haselmeier GmbH | 2008 | — |
| +2 | K993666 | Disetronic Pen P100 | Disetronic Medical Systems | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|
| K982966 | Disetronic Pen | 1998 | 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?
- Of its descendants, K982966 (Disetronic Medical Systems, 1998) has gone furthest, with 4 descendants 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.
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) | — |
https://510kreport.com/device/K942159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942159: Novopen 1.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942159
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026