510(k) · Cleared
ClearedDisposable sterile needle retractable safety syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Haiou Medical Apparatus Stock Co., Ltd. · MEG Syringe, Antistick
Cleared on Apr 10, 2015 as substantially equivalent to K113587 (Shantou Wealy Medical Instrument Co.,Ltd, 2012) after a 323-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Apr 10, 2015
- Review
- 323 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K970803 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK970803 Anti-Stick Syringe with Integral Hypodermic Needle Vanishpoint SyringeRetractable Technologies, Inc. · 1997
- 1 generation backK113587 Automatically Retractable Safety Syringe (with Fixed Needle)Shantou Wealy Medical Instrument Co.,Ltd · 2012
- This deviceK141349 Disposable sterile needle retractable safety syringeGuangdong Haiou Medical Apparatus Stock Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970803 | Anti-Stick Syringe with Integral Hypodermic Needle Vanishpoint Syringe | Retractable Technologies, Inc. | 1997 | — |
| −1 | K113587 | Automatically Retractable Safety Syringe (with Fixed Needle) | Shantou Wealy Medical Instrument Co.,Ltd | 2012 | — |
| 0 (this device) | K141349 | Disposable sterile needle retractable safety syringe | Guangdong Haiou Medical Apparatus Stock Co., Ltd. | 2015 | — |
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 |
|---|---|---|---|
| * | K113587 | Automatically Retractable Safety Syringe (with Fixed Needle)Summary page 4…inge Predicate Devices: 510K Submitted Device Manufacturer Syringe type Product Code Number K113587 Automatically Shantou Wealy Anti-stick syringe MEG Retractable… | 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 18 years and passes through 3 companies; a new generation was cleared every 14.7 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K113587.
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?
Disposable sterile needle retractable safety syringe is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141349: Disposable sterile needle retractable 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/K141349
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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