510(k) · Cleared
ClearedFlexpen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novo Nordisk, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Nov 21, 2006 as substantially equivalent to K053470 (Novo Nordisk, Inc., 2005) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1995. 17 later devices descend from it.
- Decided
- Nov 21, 2006
- Review
- 88 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K951254 (1995). 5 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK951254 Safetyglide NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
- 1 generation backK050106 Novofine Autocover 30G X 8MMNovo Nordisk, Inc. · 2005
- This deviceK062500 Flexpen NeedleNovo Nordisk, Inc. · 2006
- Descendant · cites it directly · 16 of its ownK090111 Flexpen NeedleNovo Nordisk, Inc. · 2010
- Descendant · 2 generations on · 4 of its ownK113186 Sterile Insulin Pen NeedleShina Corp. · 2012
- Descendant · cites it directly · 4 of its ownK093109 Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')Novo Nordisk, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK133100 Carefine Pen NeedleFacet Technologies · 2014
- Descendant · 2 generations on · 2 of its ownK133738 Novofine Plus 32G 4 MMNovo Nordisk, Inc. · 2014
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K090111Flexpen NeedleNovo Nordisk, Inc. · 2010 · cites it directly16descendants
- K113186Sterile Insulin Pen NeedleShina Corp. · 2012 · 2 generations on4descendants
- K093109Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5')Novo Nordisk, Inc. · 2010 · cites it directly4descendants
- K133100Carefine Pen NeedleFacet Technologies · 2014 · 2 generations on3descendants
- K133738Novofine Plus 32G 4 MMNovo Nordisk, Inc. · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951254 | Safetyglide Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | 4 |
| −1 | K050106 | Novofine Autocover 30G X 8MM | Novo Nordisk, Inc. | 2005 | — |
| 0 (this device) | K062500 | Flexpen Needle | Novo Nordisk, Inc. | 2006 | — |
| +1 | K090111 | Flexpen Needle | Novo Nordisk, Inc. | 2010 | — |
| +2 | K113186 | Sterile Insulin Pen Needle | Shina Corp. | 2012 | — |
| +1 | K093109 | Novotwist Needle, Models 30G * 8MM (1/3) 32 G Tip * 5 MM (1/5') | Novo Nordisk, Inc. | 2010 | — |
| +2 | K133100 | Carefine Pen Needle | Facet Technologies | 2014 | — |
| +2 | K133738 | Novofine Plus 32G 4 MM | Novo Nordisk, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K053470 | Novofine 32G TipSummary page 1…®)needle is a disposable needle which is substantially equivalent to Novo Nordisk's Novol'inea 32G Tip (0.23/ 0.25 mm) x 6 mm disposable needle, cleared under 5 10(k) K053470, NovoFine 7 Autocover® 30G x 8 mm, cleared under 5 10(k) KO0O0106, and to the Becton Dickinson BD Pen Needle (29G, 30G, 31I… | 2005 |
| * | K050106 | Novofine Autocover 30G X 8MM Our reading of the summary gave K000106, FDA’s number for Depilase Yaglase ND:Yag Laser System and Accessories (Fotona D.D.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “NovoFine 7 Autocover 30G x 8 mm”. | 2005 |
| * | K051899 | BD Pen NeedleSummary page 1…7 Autocover® 30G x 8 mm, cleared under 5 10(k) KO0O0106, and to the Becton Dickinson BD Pen Needle (29G, 30G, 31IG) x (5 mm, 8 mm, 12.7 mm), cleared under 5 10(k) K05 1899. The term "substantial equivalence" as used in this 5 10(k) notification is limited to the definition of substantial equiv… | 2005 |
What descends from it? (17)
See all 173 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 11 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K090111 (Novo Nordisk, Inc., 2010) has gone furthest, with 16 descendants of its own.
- 1 other device also cites its predicate K053470.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
FlexPen® needles are intended for use with pen injector devices for the subcutaneous injection of insulin and somatropin
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062500: Flexpen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062500
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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