510(k) · Cleared
ClearedInnovo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novo Nordisk A/S · FMF Syringe, Piston
Cleared on Mar 14, 2001 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 38 devices in its family, counting itself, has a Class I recall. 37 later devices descend from it.
- Decided
- Mar 14, 2001
- Review
- 36 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 0
37 later devices descend from it, 2 citing it directly. 1 of the 38 devices in this family, counting this one, has a Class I recall.
- This deviceK010359 InnovoNovo Nordisk A/S · 2001
- Descendant · cites it directly · 28 of its ownK123766 Novopen Echo, a Dial a Dose Insulin Delivery PenNovo Nordisk, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 21 of its ownK160629 InPenCompanion Medical, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 10 of its ownK190487 InPen Dose CalculatorCompanion Medical, Inc. · 2020 · Recalled
- Descendant · 4 generations on · 7 of its ownK201337 InPen SystemCompanion Medical, Inc. · 2020 · Recalled
- Descendant · cites it directly · 7 of its ownK053563 Humapen MemoirEli Lilly and Company · 2006
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193483 Basal-IQ Technology4 generations on · 2020
Most influential descendants
Showing 5 of 37 · See all- K123766Novopen Echo, a Dial a Dose Insulin Delivery PenNovo Nordisk, Inc. · 2013 · cites it directly28descendants
- K160629InPenCompanion Medical, Inc. · 2016 · 2 generations on21descendants
- K190487InPen Dose CalculatorCompanion Medical, Inc. · 2020 · 3 generations on10descendants
- K201337InPen SystemCompanion Medical, Inc. · 2020 · 4 generations on7descendants
- K053563Humapen MemoirEli Lilly and Company · 2006 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010359 | Innovo | Novo Nordisk A/S | 2001 | — |
| +1 | K123766 | Novopen Echo, a Dial a Dose Insulin Delivery Pen | Novo Nordisk, Inc. | 2013 | 1 |
| +2 | K160629 | InPen | Companion Medical, Inc. | 2016 | 1 |
| +3 | K190487 | InPen Dose Calculator | Companion Medical, Inc. | 2020 | 1 |
| +4 | K201337 | InPen System | Companion Medical, Inc. | 2020 | 2 |
| +1 | K053563 | Humapen Memoir | Eli Lilly and Company | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 4 | 1 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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.
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 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (37)
See all 372 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K193483Basal-IQ TechnologyTandem Diabetes Care, Inc. · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K123766 (Novo Nordisk, Inc., 2013) has gone furthest, with 28 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/K010359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010359: Innovo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010359
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026