510(k) · Cleared
ClearedClickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ypsomed AG · FMI Needle, Hypodermic, Single Lumen
Cleared on Jun 9, 2015 as substantially equivalent to K131125 (Ypsomed AG, 2013) after an 88-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Jun 9, 2015
- Review
- 88 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K970737 (1997). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK970737 B-D Ultra-Fine II Short 31G X 5/16 Pen NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
- 6 generations backK982399 Disetronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1998
- 5 generations backK994197 Disentronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1999
- 4 generations backK013782 Disetronic Penfine Insulin Injection Pen NeedleDisetronic Medical Systems · 2001
- 3 generations backK100436 Clickfine Pen NeedleYpsomed AG · 2010
- 2 generations backK122969 Clickfine Pen NeedleP/L Biomedical · 2012
- 1 generation backK131125 Clickfine Pen NeedleYpsomed AG · 2013
- This deviceK150662 Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names…Ypsomed AG · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970737 | B-D Ultra-Fine II Short 31G X 5/16 Pen Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | — |
| −6 | K982399 | Disetronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1998 | — |
| −5 | K994197 | Disentronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1999 | — |
| −4 | K013782 | Disetronic Penfine Insulin Injection Pen Needle | Disetronic Medical Systems | 2001 | — |
| −3 | K100436 | Clickfine Pen Needle | Ypsomed AG | 2010 | — |
| −2 | K122969 | Clickfine Pen Needle | P/L Biomedical | 2012 | — |
| −1 | K131125 | Clickfine Pen Needle | Ypsomed AG | 2013 | — |
| 0 (this device) | K150662 | Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) | Ypsomed AG | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K131125 | Clickfine Pen NeedleSummary page 4…General Hospital and Personal Use Devices Classification Panel. Panel: 80 Procode: FMI 8.5 Predicate Device: K131125 Clickfine Pen Needles 8.6 Purpose of Submission: To add a second product line of needles (Penfine Classic Pen Needle… | 2013 |
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 18 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 12 ancestors has a recall.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
The pen needles are intended for use with pen injector devices for subcutaneous injection of fluids, including insulin and exenatide.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150662: Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150662
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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