510(k) · Cleared
ClearedSafety Pen Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sandstone Medical (Suzhou), Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Feb 17, 2022 as substantially equivalent to K152514 (Ypsomed AG, 2015) after a 331-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.
- Decided
- Feb 17, 2022
- Review
- 331 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K970737 (1997). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK970737 B-D Ultra-Fine II Short 31G X 5/16 Pen NeedleBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
- 6 generations backK982399 Disetronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1998
- 5 generations backK994197 Disentronic Penfine Injection Pen NeedleDisetronic Medical Systems · 1999
- 4 generations backK102108 Clickfine Pen NeedleYpsomed AG · 2010
- 3 generations backK110312 Clickfine Autoprotect Pen NeedleYpsomed AG · 2012
- 2 generations backK131123 Clickfine Autoprotect Pen NeedleYpsomed AG · 2013
- 1 generation backK152514 Clickfine AutoProtect Pen NeedleYpsomed AG · 2015
- This deviceK210864 Safety Pen NeedleSandstone Medical (Suzhou), Inc. · 2022
- Descendant · cites it directly · 0 of its ownK253622 Safety Pen NeedleNingbo Medsun Medical Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253622Safety Pen NeedleNingbo Medsun Medical Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970737 | B-D Ultra-Fine II Short 31G X 5/16 Pen Needle | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | — |
| −6 | K982399 | Disetronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1998 | — |
| −5 | K994197 | Disentronic Penfine Injection Pen Needle | Disetronic Medical Systems | 1999 | — |
| −4 | K102108 | Clickfine Pen Needle | Ypsomed AG | 2010 | — |
| −3 | K110312 | Clickfine Autoprotect Pen Needle | Ypsomed AG | 2012 | — |
| −2 | K131123 | Clickfine Autoprotect Pen Needle | Ypsomed AG | 2013 | — |
| −1 | K152514 | Clickfine AutoProtect Pen Needle | Ypsomed AG | 2015 | — |
| 0 (this device) | K210864 | Safety Pen Needle | Sandstone Medical (Suzhou), Inc. | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K152514 | Clickfine AutoProtect Pen NeedleSummary page 4…FMI Regulation No. 880.5570 3. Legally Marketed Predicate Device Trade Name Clickfine AutoProtect Pen Needle 510(k) Number K152514 Product Code FMI Manufacturer Ypsomed AG 4. Device Description The proposed device, Safety P… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253622 | Safety Pen Needle | 2026 | 0 |
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 4 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K253622 (Ningbo Medsun Medical Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K152514.
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?
The safety pen needle is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs.
HE Model
Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.
HS Model
Additionally, the product has two safety shields, which lock in place after use (patient end) and upon removal of the needle from the pen (pen connection end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210864 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210864: Safety 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/K210864
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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