510(k) · Cleared
ClearedSingle Use Sterile Syringe with Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangxi Kelun Medical Devices Manufacturing Co.,Lt · FMF Syringe, Piston
Cleared on Mar 27, 2014 as substantially equivalent to K111841 (Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd., 2012) after a 133-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Mar 27, 2014
- Review
- 133 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K022159 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK022159 Piston Syringe & Hypodermic NeedleInternational Medsurg Connection · 2002
- 2 generations backK102969 Imc Piston SyringesInternational Medsurg Connection · 2010 · Recalled
- 1 generation backK111841 Shifeng Disposable Syringe with or Without NeedleChengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. · 2012
- This deviceK133493 Single Use Sterile Syringe with NeedleJiangxi Kelun Medical Devices Manufacturing Co.,Lt · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022159 | Piston Syringe & Hypodermic Needle | International Medsurg Connection | 2002 | — |
| −2 | K102969 | Imc Piston Syringes | International Medsurg Connection | 2010 | 40 |
| −1 | K111841 | Shifeng Disposable Syringe with or Without Needle | Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. | 2012 | — |
| 0 (this device) | K133493 | Single Use Sterile Syringe with Needle | Jiangxi Kelun Medical Devices Manufacturing Co.,Lt | 2014 | — |
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? (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 |
|---|---|---|---|
| * | K111841 | Shifeng Disposable Syringe with or Without NeedleSummary page 1…Piston/ Needle, Hypodermic, Single Lumen Regulation Number: 21 CER 880.5860 / 21 CFR 880.5570 Product Code: FMF/FMI Predicate Device: K1 11841 - Shifeng Disposable Syringe with or without needle manufactured by Chengdu Xinjin Shifeng… | 2012 |
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 12 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
Single Use Sterile Syringe with Needle is intended to inject fluids into or withdraw fluid from, parts of the body below the surface of the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133493: Single Use Sterile Syringe with Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133493
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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