510(k) · Cleared
ClearedShanchuan Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shangdong Zibo Shanchuan Medical Instruments Co. · FMF Syringe, Piston
Cleared on Jun 3, 2003 as substantially equivalent to K980181 (Terumo Medical Corp., 1998) and 1 other predicate after a 350-day review. Its family tree reaches back 2 generations to 1977. 1 later device descends from it.
- Decided
- Jun 3, 2003
- Review
- 350 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K771205 (1977). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK771205 Hypodermic SyringeTerumo America, Inc. · 1977
- 1 generation backK980181 Terumo Disposable Hypodermc SyringeTerumo Medical Corp. · 1998 · Recalled
- This deviceK021993 Shanchuan SyringeShangdong Zibo Shanchuan Medical Instruments Co. · 2003
- Descendant · cites it directly · 0 of its ownK052551 Devon Standard Syringe, Hypodermic Needle and Insulin SyringeDevon Safety Products, Inc. · 2005
Most influential descendants
Showing 1 of 1 · See all- K052551Devon Standard Syringe, Hypodermic Needle and Insulin SyringeDevon Safety Products, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771205 | Hypodermic Syringe | Terumo America, Inc. | 1977 | — |
| −1 | K980181 | Terumo Disposable Hypodermc Syringe | Terumo Medical Corp. | 1998 | 1 |
| 0 (this device) | K021993 | Shanchuan Syringe | Shangdong Zibo Shanchuan Medical Instruments Co. | 2003 | — |
| +1 | K052551 | Devon Standard Syringe, Hypodermic Needle and Insulin Syringe | Devon Safety Products, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K980181 | Terumo Disposable Hypodermc SyringeSummary page 3…substantially equivalent in intended uses, labeling, design and materials, specifications and performance to the predicate Terumo Disposable Hypodermic Syringe (K980 181). Any noted differences between the two devices do not raise new issues of the safety and effectiveness. All the results demo… | 1998 |
| * | K941657 | BD Micro Fine, Ultra Fine, and Allergy SyringeSummary page 1…Hypodermic single lumen needle 21 C.F.R. 880.5570 Class I 1 Predicate device Terumo Disposable Hypodermic Syringe (K980 18I); BD Insulin Syringe (K941657). Intended Use: The SHANCHUAN Piston Syringe is design for medical purposes to inject fluids into or withdr… | 1994 |
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 |
|---|---|---|---|
| K052551 | Devon Standard Syringe, Hypodermic Needle and Insulin Syringe | 2005 | 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 26 years and passes through 3 companies; a new generation was cleared every 20.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K052551 (Devon Safety Products, Inc., 2005) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K980181.
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?
The SHANCHUAN Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle.
The SHANCHUAN Insulin Syringe is design for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needlehub assembly. The needle shield is colored orange.
The syringe fluid path is sterile, non-toxic, non-pyrogen and single use, disposable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021993: Shanchuan Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021993
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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