510(k) · Cleared
ClearedClickfine Autoprotect 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 Jan 26, 2012 as substantially equivalent to K102108 (Ypsomed AG, 2010) after a 358-day review. Its family tree reaches back 4 generations to 1997. 9 later devices descend from it.
- Decided
- Jan 26, 2012
- Review
- 358 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K970737 (1997). 5 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK970737 B-D Ultra-Fine II Short 31G X 5/16 Pen NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
- 3 generations backK982399 Disetronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1998
- 2 generations backK994197 Disentronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1999
- 1 generation backK102108 Clickfine Pen NeedleYpsomed AG · 2010
- This deviceK110312 Clickfine Autoprotect Pen NeedleYpsomed AG · 2012
- Descendant · cites it directly · 8 of its ownK131123 Clickfine Autoprotect Pen NeedleYpsomed AG · 2013
- Descendant · 2 generations on · 7 of its ownK152514 Clickfine AutoProtect Pen NeedleYpsomed AG · 2015
- Descendant · 3 generations on · 4 of its ownK181447 Safety insulin needle for single useBerpu Medical Technology Co., Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK210864 Safety Pen NeedleSandstone Medical (Suzhou), Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK192677 Safety Insulin Pen NeedleJiangsu Caina Medical Co.,Ltd · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K131123Clickfine Autoprotect Pen NeedleYpsomed AG · 2013 · cites it directly8descendants
- K152514Clickfine AutoProtect Pen NeedleYpsomed AG · 2015 · 2 generations on7descendants
- K181447Safety insulin needle for single useBerpu Medical Technology Co., Ltd. · 2019 · 3 generations on4descendants
- K210864Safety Pen NeedleSandstone Medical (Suzhou), Inc. · 2022 · 3 generations on1descendant
- K192677Safety Insulin Pen NeedleJiangsu Caina Medical Co.,Ltd · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970737 | B-D Ultra-Fine II Short 31G X 5/16 Pen Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | — |
| −3 | K982399 | Disetronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1998 | — |
| −2 | K994197 | Disentronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1999 | — |
| −1 | K102108 | Clickfine Pen Needle | Ypsomed AG | 2010 | — |
| 0 (this device) | K110312 | Clickfine Autoprotect Pen Needle | Ypsomed AG | 2012 | — |
| +1 | K131123 | Clickfine Autoprotect Pen Needle | Ypsomed AG | 2013 | — |
| +2 | K152514 | Clickfine AutoProtect Pen Needle | Ypsomed AG | 2015 | — |
| +3 | K181447 | Safety insulin needle for single use | Berpu Medical Technology Co., Ltd. | 2019 | — |
| +3 | K210864 | Safety Pen Needle | Sandstone Medical (Suzhou), Inc. | 2022 | — |
| +4 | K192677 | Safety Insulin Pen Needle | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 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 |
|---|---|---|---|
| * | K102108 | Clickfine Pen NeedleSummary page 1…equivalence of the modified Ypsomed Clickfine AutoProtect Pen Needles to the Clickfine Pen Needles cleared for legal marketing in the USA per 5 10(k) file K 102 108. 7.6. Substantial Equivalence: The Ypsomed Clickfine AutoProtect Pen Needles are substantially equivalent to the Clickf… | 2010 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131123 | Clickfine Autoprotect Pen Needle | 2013 | 8 |
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 15 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K131123 (Ypsomed AG, 2013) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K102108.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 AutoProtect pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen.
Additionally, after withdrawal of the pen needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110312: Clickfine Autoprotect 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/K110312
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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