510(k) · Cleared
ClearedSterile Hypodermic Needle for Single Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangsu Shenli Medical Production Co., Ltd. · FMI Needle, Hypodermic, Single Lumen
Cleared on May 18, 2018 as substantially equivalent to K102584 (International Medsurg Connection, 2011) after a 108-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- May 18, 2018
- Review
- 108 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944355 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
- 2 generations backK052474 Nipro Hypodermic NeedleNipro Medical Corp. · 2005
- 1 generation backK102584 Imc Hypodermic NeedleInternational Medsurg Connection · 2011 · Recalled
- This deviceK180259 Sterile Hypodermic Needle for Single UseJiangsu Shenli Medical Production Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944355 | Nipro Branded Disposable Syringes, Needles | Nissho Corp. | 1994 | — |
| −2 | K052474 | Nipro Hypodermic Needle | Nipro Medical Corp. | 2005 | — |
| −1 | K102584 | Imc Hypodermic Needle | International Medsurg Connection | 2011 | 20 |
| 0 (this device) | K180259 | Sterile Hypodermic Needle for Single Use | Jiangsu Shenli Medical Production Co., Ltd. | 2018 | — |
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 |
|---|---|---|---|
| * | K102584 | Imc Hypodermic NeedleSummary page 4…vice International Medsurg Sterile Hypodermic Needle for IMC Hypodermic Needle K102584 Connection Single Use IV. Device Description: The sub… | 2011 |
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 24 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 3 other devices also cite its predicate K102584.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
This device is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180259: Sterile Hypodermic Needle for Single Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180259
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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