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 Nov 23, 2010 as substantially equivalent to K994197 (Disetronic Medical Systems, 1999) after a 119-day review. Its family tree reaches back 3 generations to 1997. 13 later devices descend from it.
- Decided
- Nov 23, 2010
- Review
- 119 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970737 (1997). 4 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK970737 B-D Ultra-Fine II Short 31G X 5/16 Pen NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
- 2 generations backK982399 Disetronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1998
- 1 generation backK994197 Disentronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1999
- This deviceK102108 Clickfine Pen NeedleYpsomed AG · 2010
- Descendant · cites it directly · 9 of its ownK110312 Clickfine Autoprotect Pen NeedleYpsomed AG · 2012
- Descendant · 2 generations on · 8 of its ownK131123 Clickfine Autoprotect Pen NeedleYpsomed AG · 2013
- Descendant · 3 generations on · 7 of its ownK152514 Clickfine AutoProtect Pen NeedleYpsomed AG · 2015
- Descendant · 4 generations on · 4 of its ownK181447 Safety insulin needle for single useBerpu Medical Technology Co., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK122971 Clickfine Pen NeedleP/L Biomedical · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K110312Clickfine Autoprotect Pen NeedleYpsomed AG · 2012 · cites it directly9descendants
- K131123Clickfine Autoprotect Pen NeedleYpsomed AG · 2013 · 2 generations on8descendants
- K152514Clickfine AutoProtect Pen NeedleYpsomed AG · 2015 · 3 generations on7descendants
- K181447Safety insulin needle for single useBerpu Medical Technology Co., Ltd. · 2019 · 4 generations on4descendants
- K122971Clickfine Pen NeedleP/L Biomedical · 2012 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970737 | B-D Ultra-Fine II Short 31G X 5/16 Pen Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | — |
| −2 | K982399 | Disetronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1998 | — |
| −1 | K994197 | Disentronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1999 | — |
| 0 (this device) | K102108 | Clickfine Pen Needle | Ypsomed AG | 2010 | — |
| +1 | K110312 | Clickfine Autoprotect Pen Needle | Ypsomed AG | 2012 | — |
| +2 | K131123 | Clickfine Autoprotect Pen Needle | Ypsomed AG | 2013 | — |
| +3 | K152514 | Clickfine AutoProtect Pen Needle | Ypsomed AG | 2015 | — |
| +4 | K181447 | Safety insulin needle for single use | Berpu Medical Technology Co., Ltd. | 2019 | — |
| +1 | K122971 | Clickfine Pen Needle | P/L Biomedical | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 4 | 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? (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 |
|---|---|---|---|
| * | K994197 | Disentronic Penfine Injection Pen NeedleSummary page 1…Pen Needles. Substantial Equivalence: The Ypsomed Clickfine Pen Needles are substantially equivalent to the Disetronic Penfine Injection Pen Needles (K9941 97). The equivalence is supported by the attached documentation. 7.6 Device Description The Ypsomed Clickfine Pen Nee… | 1999 |
What descends from it? (13)
See all 132 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 13 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K110312 (Ypsomed AG, 2012) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K994197.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 the hypodermic injection of fluids into the body when attached to an injection pen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102108: 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/K102108
Report an extraction error
Are you the manufacturer?
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