510(k) · Cleared
ClearedSafety Insulin Pen Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Kindly Medical Devices Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on Oct 14, 2022 as substantially equivalent to K181447 (Berpu Medical Technology Co., Ltd., 2019) after a 380-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Oct 14, 2022
- Review
- 380 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 backK181447 Safety insulin needle for single useBerpu Medical Technology Co., Ltd. · 2019
- This deviceK213183 Safety Insulin Pen NeedlesZhejiang Kindly Medical Devices Co., Ltd. · 2022
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 | K181447 | Safety insulin needle for single use | Berpu Medical Technology Co., Ltd. | 2019 | — |
| 0 (this device) | K213183 | Safety Insulin Pen Needles | Zhejiang Kindly Medical Devices Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K181447 | Safety insulin needle for single useSummary page 4…mmon Name: Hypodermic single lumen needle Classification Panel: General Hospital Regulatory Class: II Product Code: FMI III. PREDICATE DEVICE Primary predicate device: K181447 Safety insulin needle for single use 15‐2 === Page 5 ==… | 2019 |
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 5 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 2 other devices also cite its predicate K181447.
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?
Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids.
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/K213183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213183: Safety Insulin Pen Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213183
Report an extraction error
Are you the manufacturer?
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