510(k) · Cleared
ClearedSafety Auto-Disable Syrine with Needle (Auto-Lock)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Intmed Medical Appliance Co., Ltd. · MEG Syringe, Antistick
Cleared on Nov 4, 2015 as substantially equivalent to K132120 (Beijing Wantefu Medical Apparatus Co., Ltd., 2013) after a 330-day review. Its family tree reaches back 3 generations to 1998. 3 later devices descend from it.
- Decided
- Nov 4, 2015
- Review
- 330 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K980069 (1998). 5 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK980069 Vanishpoint SyringeRetractable Technologies, Inc. · 1998
- 2 generations backK023752 BD Integra SyringeBd · 2003 · Recalled
- 1 generation backK132120 WTF Secura Syringe and NeedleBeijing Wantefu Medical Apparatus Co., Ltd. · 2013
- This deviceK143497 Safety Auto-Disable Syrine with Needle (Auto-Lock)Guangdong Intmed Medical Appliance Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK231727 Sterile Auto-Disable Syringes with/without Needle for Single UseWepon Medical Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK210229 Sterile Auto-Disable Syringes with/without Needle for Single UseZhejiang Kangkang Medical-Devices Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK211210 Sterile Auto-Disable Syringes with/without Needle for Single UseAzur Medical Company, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K231727Sterile Auto-Disable Syringes with/without Needle for Single UseWepon Medical Technology Co., Ltd. · 2023 · cites it directly0descendants
- K210229Sterile Auto-Disable Syringes with/without Needle for Single UseZhejiang Kangkang Medical-Devices Co., Ltd. · 2022 · cites it directly0descendants
- K211210Sterile Auto-Disable Syringes with/without Needle for Single UseAzur Medical Company, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980069 | Vanishpoint Syringe | Retractable Technologies, Inc. | 1998 | — |
| −2 | K023752 | BD Integra Syringe | Bd | 2003 | 2 |
| −1 | K132120 | WTF Secura Syringe and Needle | Beijing Wantefu Medical Apparatus Co., Ltd. | 2013 | — |
| 0 (this device) | K143497 | Safety Auto-Disable Syrine with Needle (Auto-Lock) | Guangdong Intmed Medical Appliance Co., Ltd. | 2015 | — |
| +1 | K231727 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Wepon Medical Technology Co., Ltd. | 2023 | — |
| +1 | K210229 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2022 | — |
| +1 | K211210 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Azur Medical Company, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 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 MEG? 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? (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 |
|---|---|---|---|
| * | K132120 | WTF Secura Syringe and NeedleSummary page 4…pany Product 510(k) Code Number WTF Secura Safety Beijing WanTeFu MEG, FMF, K132120 Syringe (with Needle) Medical Apparatus Co., and FMI Ltd 2. Reference Predicate Devices: Devi… | 2013 |
| † | K011103 | BD Spring Based Syringe | 2001 |
| † | K023752 | BD Integra Syringe | 2003 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K231727 (Wepon Medical Technology Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132120.
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
The Safety Auto-Disable Syringe with Needle (Auto-Lock) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.
It has a detachable needle with a dedicated fitting. The Safety Auto-Disable Syringe with Needle (Auto-Lock) contains an inner mechanism used to allow the needle to be retracted inside the plunger rod of the syringe after the operator’s thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143497 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143497: Safety Auto-Disable Syrine with Needle (Auto-Lock).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143497
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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