510(k) · Cleared
ClearedDisposable Insulin Pen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ningbo Medsun Medical Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Nov 17, 2022 as substantially equivalent to K170846 (Jiangsu Caina Technology Co., Ltd., 2017) and 1 other predicate after a 206-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Nov 17, 2022
- Review
- 206 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K970737 (1997). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK970737 B-D Ultra-Fine II Short 31G X 5/16 Pen NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
- 5 generations between
- 3 generations backK152514 Clickfine AutoProtect Pen NeedleYpsomed AG · 2015
- 2 generations backK181447 Safety insulin needle for single useBerpu Medical Technology Co., Ltd. · 2019
- 1 generation backK192677 Safety Insulin Pen NeedleJiangsu Caina Medical Co.,Ltd · 2020
- This deviceK221178 Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd. · 2022
Show all 9 generations
- Root · 9 generations backK970737 B-D Ultra-Fine II Short 31G X 5/16 Pen NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
- 8 generations backK982399 Disetronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1998
- 7 generations backK994197 Disentronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1999
- 6 generations backK102108 Clickfine Pen NeedleYpsomed AG · 2010
- 5 generations backK110312 Clickfine Autoprotect Pen NeedleYpsomed AG · 2012
- 4 generations backK131123 Clickfine Autoprotect Pen NeedleYpsomed AG · 2013
- 3 generations backK152514 Clickfine AutoProtect Pen NeedleYpsomed AG · 2015
- 2 generations backK181447 Safety insulin needle for single useBerpu Medical Technology Co., Ltd. · 2019
- 1 generation backK192677 Safety Insulin Pen NeedleJiangsu Caina Medical Co.,Ltd · 2020
- This deviceK221178 Disposable Insulin Pen NeedleNingbo Medsun Medical Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K970737 | B-D Ultra-Fine II Short 31G X 5/16 Pen Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | — |
| −8 | K982399 | Disetronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1998 | — |
| −7 | K994197 | Disentronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1999 | — |
| −6 | K102108 | Clickfine Pen Needle | Ypsomed AG | 2010 | — |
| −5 | K110312 | Clickfine Autoprotect Pen Needle | Ypsomed AG | 2012 | — |
| −4 | K131123 | Clickfine Autoprotect Pen Needle | Ypsomed AG | 2013 | — |
| −3 | K152514 | Clickfine AutoProtect Pen Needle | Ypsomed AG | 2015 | — |
| −2 | K181447 | Safety insulin needle for single use | Berpu Medical Technology Co., Ltd. | 2019 | — |
| −1 | K192677 | Safety Insulin Pen Needle | Jiangsu Caina Medical Co.,Ltd | 2020 | — |
| 0 (this device) | K221178 | Disposable Insulin Pen Needle | Ningbo Medsun Medical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K170846 | Disposable Insulin Pen NeedleSummary page 4…al Hospital 4. Predicate device 4.1 Primary Predicate device A Manufacturer: Jiangsu Caina Technology Co., Ltd. Device name: Disposable Insulin Pen Needle 510(k) number: K170846 Secondary Predicate device B Manufacturer: Jiangsu Caina Technology Co., Ltd. Device name: Safety Pen Needle 510(k) number: K1926… | 2017 |
| * | K192677 | Safety Insulin Pen NeedleSummary page 4…ble Insulin Pen Needle 510(k) number: K170846 Secondary Predicate device B Manufacturer: Jiangsu Caina Technology Co., Ltd. Device name: Safety Pen Needle 510(k) number: K192677 5.Device description Disposable Insulin Pen Needle, could be divided into Model CT (normal type) and model ST(safety type) ac… | 2020 |
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 25 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 21 ancestors have a recall of any class.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Disposable Insulin Pen Needle(Model CT) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
Disposable Insulin Pen Needle(Model ST) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, it has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221178: Disposable Insulin 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/K221178
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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