510(k) · Cleared
ClearedClickfine Pen Needle
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 Jul 5, 2013 as substantially equivalent to K122969 (P/L Biomedical, 2012) and 3 other predicates after a 74-day review. Its family tree reaches back 6 generations to 1997. 1 later device descends from it.
- Decided
- Jul 5, 2013
- Review
- 74 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K970737 (1997). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK970737 B-D Ultra-Fine II Short 31G X 5/16 Pen NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
- 5 generations backK982399 Disetronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1998
- 4 generations backK994197 Disentronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1999
- 3 generations backK013782 Disetronic Penfine Insulin Injection Pen NeedleDisetronic Medical Systems · 2001
- 2 generations backK100436 Clickfine Pen NeedleYpsomed AG · 2010
- 1 generation backK122969 Clickfine Pen NeedleP/L Biomedical · 2012
- This deviceK131125 Clickfine Pen NeedleYpsomed AG · 2013
- Descendant · cites it directly · 0 of its ownK150662 Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names…Ypsomed AG · 2015
Most influential descendants
Showing 1 of 1 · See all- K150662Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)Ypsomed AG · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970737 | B-D Ultra-Fine II Short 31G X 5/16 Pen Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | — |
| −5 | K982399 | Disetronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1998 | — |
| −4 | K994197 | Disentronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1999 | — |
| −3 | K013782 | Disetronic Penfine Insulin Injection Pen Needle | Disetronic Medical Systems | 2001 | — |
| −2 | K100436 | Clickfine Pen Needle | Ypsomed AG | 2010 | — |
| −1 | K122969 | Clickfine Pen Needle | P/L Biomedical | 2012 | — |
| 0 (this device) | K131125 | Clickfine Pen Needle | Ypsomed AG | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122969 | Clickfine Pen NeedleSummary page 1…Counter (OTC) for all compatible injection pens. 7.6 Substantial Equivalence: The Clickfine Pen Needle is substantially equivalent to the Clickfine Pen Needles (K 122969 and K 12297 1) and the BD Pen Needles (KI 110105, K 100005 and K(05 1899). 7.7 Device Description The Clickfine Pe… | 2012 |
| * | K122971 | Clickfine Pen NeedleSummary page 1…for all compatible injection pens. 7.6 Substantial Equivalence: The Clickfine Pen Needle is substantially equivalent to the Clickfine Pen Needles (K 122969 and K 12297 1) and the BD Pen Needles (KI 110105, K 100005 and K(05 1899). 7.7 Device Description The Clickfine Pen Needles are… | 2012 |
| Kept off the family tree | K101105 | FDA’s K101105 is Powder-Free, Natural Color, Latex Examination Glove Model: MEPF1 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2010 |
| * | K100005 | BD Pen NeedleSummary page 1…al Equivalence: The Clickfine Pen Needle is substantially equivalent to the Clickfine Pen Needles (K 122969 and K 12297 1) and the BD Pen Needles (KI 110105, K 100005 and K(05 1899). 7.7 Device Description The Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed… | 2010 |
| * | K051899 | BD Pen NeedleSummary page 2…bine the Indications cleared for the Clickfine Pen Needle (K122969 and K122971) with the wording in the predicate device BD Pen Needle (KI 10105, K100005 and K051899): The Clickfine Pen Needle is intended for use with pen injector devices for subcutaneous injection of fluids, inclu… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150662 | Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) | 2015 | 0 |
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 16 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K150662 (Ypsomed AG, 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Clickfine Pen Needle is 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/K131125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131125: Clickfine Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131125
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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