510(k) · Cleared
ClearedShifeng Disposable Syringe with or Without Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. · FMF Syringe, Piston
Cleared on Mar 1, 2012 as substantially equivalent to K102969 (International Medsurg Connection, 2010) after a 246-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Mar 1, 2012
- Review
- 246 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022159 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK022159 Piston Syringe & Hypodermic NeedleInternational Medsurg Connection · 2002
- 1 generation backK102969 Imc Piston SyringesInternational Medsurg Connection · 2010 · Recalled
- This deviceK111841 Shifeng Disposable Syringe with or Without NeedleChengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK133493 Single Use Sterile Syringe with NeedleJiangxi Kelun Medical Devices Manufacturing Co.,Lt · 2014
Most influential descendants
Showing 1 of 1 · See all- K133493Single Use Sterile Syringe with NeedleJiangxi Kelun Medical Devices Manufacturing Co.,Lt · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022159 | Piston Syringe & Hypodermic Needle | International Medsurg Connection | 2002 | — |
| −1 | K102969 | Imc Piston Syringes | International Medsurg Connection | 2010 | 40 |
| 0 (this device) | K111841 | Shifeng Disposable Syringe with or Without Needle | Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. | 2012 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K102969 | Imc Piston SyringesSummary page 1…Medical Apparatus & Instruments Co., Ltd., China is substantially equivalent to the MC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K1 02969. (Refer to Plc 1) Page 3 of 9 Company: Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. P… | 2010 |
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 |
|---|---|---|---|
| K133493 | Single Use Sterile Syringe with Needle | 2014 | 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 10 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K133493 (Jiangxi Kelun Medical Devices Manufacturing Co.,Lt, 2014) has gone furthest, with 0 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. 2012, 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?
The Shifeng Disposable Syuinge with or without needle are intended to be used to inject fluid into, or withdraw fluids from, part of the body below the surface of the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111841 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111841: Shifeng Disposable Syringe with or Without Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111841
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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