510(k) · Cleared
ClearedSafety 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 Mar 18, 2026 as substantially equivalent to K210864 (Sandstone Medical (Suzhou), Inc., 2022) after a 120-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Mar 18, 2026
- Review
- 120 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K970737 (1997). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK970737 B-D Ultra-Fine II Short 31G X 5/16 Pen NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
- 7 generations backK982399 Disetronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1998
- 6 generations backK994197 Disentronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1999
- 5 generations backK102108 Clickfine Pen NeedleYpsomed AG · 2010
- 4 generations backK110312 Clickfine Autoprotect Pen NeedleYpsomed AG · 2012
- 3 generations backK131123 Clickfine Autoprotect Pen NeedleYpsomed AG · 2013
- 2 generations backK152514 Clickfine AutoProtect Pen NeedleYpsomed AG · 2015
- 1 generation backK210864 Safety Pen NeedleSandstone Medical (Suzhou), Inc. · 2022
- This deviceK253622 Safety Pen NeedleNingbo Medsun Medical Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K970737 | B-D Ultra-Fine II Short 31G X 5/16 Pen Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | — |
| −7 | K982399 | Disetronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1998 | — |
| −6 | K994197 | Disentronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1999 | — |
| −5 | K102108 | Clickfine Pen Needle | Ypsomed AG | 2010 | — |
| −4 | K110312 | Clickfine Autoprotect Pen Needle | Ypsomed AG | 2012 | — |
| −3 | K131123 | Clickfine Autoprotect Pen Needle | Ypsomed AG | 2013 | — |
| −2 | K152514 | Clickfine AutoProtect Pen Needle | Ypsomed AG | 2015 | — |
| −1 | K210864 | Safety Pen Needle | Sandstone Medical (Suzhou), Inc. | 2022 | — |
| 0 (this device) | K253622 | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K210864 | Safety Pen NeedleSummary page 5…: FMI Review Panel: General Hospital 4. Predicate Device Manufacturer: Sandstone Medical (Suzhou) Inc. Device Name: Safety Pen Needle 510(k) Number: K210864 5. Device Description Safety Pen Needle, could be divided into Model SD and Model SDW. Model… | 2022 |
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 29 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 11 ancestors has 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. 2026, 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 Safety pen needle is intended for use with pen injector devices for subcutaneous injection of drugs. It has sharps protection feature of the patient-end and cartridge-end. For Model SD, the needle tube tip is 3 bevel. For Model SDW, the needle tube tip is 5 bevel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253622 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253622: Safety Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253622
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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