510(k) · Cleared
ClearedYixin Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jiangxi Sanxin (Eversincere) Medical Devices Group · MEG Syringe, Antistick
Cleared on Mar 8, 2005 after a 216-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 5 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Mar 8, 2005
- Review
- 216 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- This deviceK042102 Yixin Safety SyringeJiangxi Sanxin (Eversincere) Medical Devices Group · 2005
- Descendant · cites it directly · 3 of its ownK050999 YI Xin Sterile Syringe for Single UseJiangxi Sanxin (Eversincere) Medical Devices Group · 2005 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK081436 Invirostripe 3ML, 5ML, 10ML Luer Lock SyringesInviro Medical Devices, Inc. · 2008
- Descendant · 3 generations on · 1 of its ownK101359 Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML)Inviro Medical Devices, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 0 of its ownK222744 Sol-M Luer Lock SyringeSol-Millennium Medical, Inc. · 2022
Class I recalls in this family
- K050999 YI Xin Sterile Syringe for Single Usecites it directly · 2005
Most influential descendants
Showing 4 of 4 · See all- K050999YI Xin Sterile Syringe for Single UseJiangxi Sanxin (Eversincere) Medical Devices Group · 2005 · cites it directly3descendants
- K081436Invirostripe 3ML, 5ML, 10ML Luer Lock SyringesInviro Medical Devices, Inc. · 2008 · 2 generations on2descendants
- K101359Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML)Inviro Medical Devices, Inc. · 2010 · 3 generations on1descendant
- K222744Sol-M Luer Lock SyringeSol-Millennium Medical, Inc. · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042102 | Yixin Safety Syringe | Jiangxi Sanxin (Eversincere) Medical Devices Group | 2005 | — |
| +1 | K050999 | YI Xin Sterile Syringe for Single Use | Jiangxi Sanxin (Eversincere) Medical Devices Group | 2005 | Class I |
| +2 | K081436 | Invirostripe 3ML, 5ML, 10ML Luer Lock Syringes | Inviro Medical Devices, Inc. | 2008 | — |
| +3 | K101359 | Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML) | Inviro Medical Devices, Inc. | 2010 | 1 |
| +4 | K222744 | Sol-M Luer Lock Syringe | Sol-Millennium Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 1 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 MEG device
- #1 K192551 1ml Luer Slip or Luer Lock Syringe, Syringe…score 19.6 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050999 | YI Xin Sterile Syringe for Single Use Class I | 2005 | 3 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K050999YI Xin Sterile Syringe for Single UseJiangxi Sanxin (Eversincere) Medical Devices Group · 2005 · Cites it directly · ◆ in the 2005 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- Of its descendants, K050999 (Jiangxi Sanxin (Eversincere) Medical Devices Group, 2005) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEG
229in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEG
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MEG
148in 2025
MAUDE reports naming product code MEG, 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 | 8 | 100 | 0 | 21 |
| 2008 | 4 | 145 | 1 | 20 |
| 2009 | 2 | — | 0 | 26 |
| 2010 | 2 | — | 1 | 34 |
| 2011 | 5 | 113 | 0 | 34 |
| 2012 | 5 | 109 | 0 | 22 |
| 2013 | 1 | — | 5 | 27 |
| 2014 | 5 | 153 | 0 | 36 |
| 2015 | 7 | 253 | 1 | 51 |
| 2016 | 3 | 179 | 0 | 94 |
| 2017 | 3 | 130 | 0 | 181 |
| 2018 | 1 | — | 0 | 269 |
| 2019 | 4 | 249 | 0 | 497 |
| 2020 | 4 | 296 | 0 | 353 |
| 2021 | 5 | 152 | 0 | 541 |
| 2022 | 13 | 216 | 0 | 170 |
| 2023 | 5 | 229 | 0 | 120 |
| 2024 | 0 | — | 1 (1) | 112 |
| 2025 | 1 | — | 0 | 148 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
YI XIN Safety Syringe is a sterile, single-use, disposable and nonreusable, manual retractable safety syringe intended for injection of fluids into or withdraw fluids from the body, while reducing the risk of sharps injuries and the potential for syringe reuse. The safety syringes are for IV and IM use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042102: Yixin Safety Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042102
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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