510(k) · Cleared
ClearedPiston Syringe & Hypodermic Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Medsurg Connection · FMF Syringe, Piston
Cleared on Nov 7, 2002 after a 128-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Nov 7, 2002
- Review
- 128 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK022159 Piston Syringe & Hypodermic NeedleInternational Medsurg Connection · 2002
- Descendant · cites it directly · 2 of its ownK102969 Imc Piston SyringesInternational Medsurg Connection · 2010 · Recalled
- Descendant · 2 generations on · 1 of its ownK111841 Shifeng Disposable Syringe with or Without NeedleChengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. · 2012
- Descendant · 3 generations on · 0 of its ownK133493 Single Use Sterile Syringe with NeedleJiangxi Kelun Medical Devices Manufacturing Co.,Lt · 2014
Most influential descendants
Showing 3 of 3 · See all- K102969Imc Piston SyringesInternational Medsurg Connection · 2010 · cites it directly2descendants
- K111841Shifeng Disposable Syringe with or Without NeedleChengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. · 2012 · 2 generations on1descendant
- K133493Single Use Sterile Syringe with NeedleJiangxi Kelun Medical Devices Manufacturing Co.,Lt · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022159 | Piston Syringe & Hypodermic Needle | International Medsurg Connection | 2002 | — |
| +1 | K102969 | Imc Piston Syringes | International Medsurg Connection | 2010 | 40 |
| +2 | K111841 | Shifeng Disposable Syringe with or Without Needle | Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. | 2012 | — |
| +3 | K133493 | Single Use Sterile Syringe with Needle | Jiangxi Kelun Medical Devices Manufacturing Co.,Lt | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 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 |
|---|---|---|---|
| * | — | Becton Dickinson Piston Syringes Named without a submission number | |
| * | — | Nipro needles Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102969 | Imc Piston Syringes | 2010 | 2 |
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?
- Of its descendants, K102969 (International Medsurg Connection, 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
This device is intended for inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022159: Piston Syringe & Hypodermic Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022159
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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