510(k) · Cleared
ClearedSterile Insulin Pen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shina Corp. · FMI Needle, Hypodermic, Single Lumen
Cleared on Apr 12, 2012 as substantially equivalent to K100812 (Ultimed, Inc., 2010) and 2 other predicates after a 167-day review. Its family tree reaches back 4 generations to 1995. 4 later devices descend from it.
- Decided
- Apr 12, 2012
- Review
- 167 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K951254 (1995). 15 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK951254 Safetyglide NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
- 3 generations backK050106 Novofine Autocover 30G X 8MMNovo Nordisk, Inc. · 2005
- 2 generations backK062500 Flexpen NeedleNovo Nordisk, Inc. · 2006
- 1 generation backK090111 Flexpen NeedleNovo Nordisk, Inc. · 2010
- This deviceK113186 Sterile Insulin Pen NeedleShina Corp. · 2012
- Descendant · cites it directly · 1 of its ownK210748 Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK152877 SureFine Pen NeedleShina Med Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK260855 Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK250658 SureFine Pen NeedleShina Med Corporation · 2025
Most influential descendants
Showing 4 of 4 · See all- K210748Well-life TM Pen Needles, Well-life TM Safety Pen NeedlesW. L. Med Co., Ltd. · 2022 · cites it directly1descendant
- K152877SureFine Pen NeedleShina Med Corporation · 2016 · cites it directly1descendant
- K260855Profoject™ Safety Pen NeedlesCMT Health PTE., Ltd. · 2026 · 2 generations on0descendants
- K250658SureFine Pen NeedleShina Med Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951254 | Safetyglide Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | 4 |
| −3 | K050106 | Novofine Autocover 30G X 8MM | Novo Nordisk, Inc. | 2005 | — |
| −2 | K062500 | Flexpen Needle | Novo Nordisk, Inc. | 2006 | — |
| −1 | K090111 | Flexpen Needle | Novo Nordisk, Inc. | 2010 | — |
| 0 (this device) | K113186 | Sterile Insulin Pen Needle | Shina Corp. | 2012 | — |
| +1 | K210748 | Well-life TM Pen Needles, Well-life TM Safety Pen Needles | W. L. Med Co., Ltd. | 2022 | — |
| +1 | K152877 | SureFine Pen Needle | Shina Med Corporation | 2016 | — |
| +2 | K260855 | Profoject™ Safety Pen Needles | CMT Health PTE., Ltd. | 2026 | — |
| +2 | K250658 | SureFine Pen Needle | Shina Med Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K100812 | Ulticare Disposable Pen NeedlesSummary page 2…CORPORATION Ultie Inc _ company 510(k) Number N/A K 100812 K(090111 K 100005 Thhnaegis The UltiCare Disposabl… | 2010 |
| * | K090111 | Flexpen NeedleSummary page 2…ION Ultie Inc _ company 510(k) Number N/A K 100812 K(090111 K 100005 Thhnaegis The UltiCare Disposable FlexPen needle is… | 2010 |
| * | K100005 | BD Pen NeedleSummary page 2…nc _ company 510(k) Number N/A K 100812 K(090111 K 100005 Thhnaegis The UltiCare Disposable FlexPen needle is Tesinen… | 2010 |
What descends from it? (4)
2 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 17 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K210748 (W. L. Med Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K100812.
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?
ShinaPen® is intended for use with pen injector devices for the subcutaneous injection of insulin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113186 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113186: Sterile Insulin Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113186
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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