510(k) · Cleared
ClearedAutomatically Retractable Safety Syringe (with Fixed Needle)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shantou Wealy Medical Instrument Co.,Ltd · MEG Syringe, Antistick
Cleared on Feb 24, 2012 as substantially equivalent to K970803 (Retractable Technologies, Inc., 1997) after an 81-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Feb 24, 2012
- Review
- 81 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970803 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK970803 Anti-Stick Syringe with Integral Hypodermic Needle Vanishpoint SyringeRetractable Technologies, Inc. · 1997
- This deviceK113587 Automatically Retractable Safety Syringe (with Fixed Needle)Shantou Wealy Medical Instrument Co.,Ltd · 2012
- Descendant · cites it directly · 1 of its ownK141640 Automatically Retractable Safety Syringes with Fixed NeedleShantou Wealy Medical Instrument Co.,Ltd · 2014
- Descendant · 2 generations on · 0 of its ownK222452 Disposable Automatically Retractable Safety Syringes (with…Shantou Wealy Medical Instrument Co.,Ltd · 2022
- Descendant · cites it directly · 0 of its ownK141349 Disposable sterile needle retractable safety syringeGuangdong Haiou Medical Apparatus Stock Co., Ltd. · 2015
Most influential descendants
Showing 3 of 3 · See all- K141640Automatically Retractable Safety Syringes with Fixed NeedleShantou Wealy Medical Instrument Co.,Ltd · 2014 · cites it directly1descendant
- K222452Disposable Automatically Retractable Safety Syringes (with detachable needle)Shantou Wealy Medical Instrument Co.,Ltd · 2022 · 2 generations on0descendants
- K141349Disposable sterile needle retractable safety syringeGuangdong Haiou Medical Apparatus Stock Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970803 | Anti-Stick Syringe with Integral Hypodermic Needle Vanishpoint Syringe | Retractable Technologies, Inc. | 1997 | — |
| 0 (this device) | K113587 | Automatically Retractable Safety Syringe (with Fixed Needle) | Shantou Wealy Medical Instrument Co.,Ltd | 2012 | — |
| +1 | K141640 | Automatically Retractable Safety Syringes with Fixed Needle | Shantou Wealy Medical Instrument Co.,Ltd | 2014 | — |
| +2 | K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle) | Shantou Wealy Medical Instrument Co.,Ltd | 2022 | — |
| +1 | K141349 | Disposable sterile needle retractable safety syringe | Guangdong Haiou Medical Apparatus Stock Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K970803 | Anti-Stick Syringe with Integral Hypodermic Needle Vanishpoint SyringeSummary page 2…Manufacturer K Number Submitted Device Anti-Stick Retractable K970803 Automatically Syringe With Technologies,… | 1997 |
What descends from it? (3)
2 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?
How does its category compare?
All MEG devicesMEG Syringe, Antistick: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Automatically Retractable Safety Syringe (with fixed needle) (5cc/mi 22x1-1/4) 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 a patient.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K113587 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113587: Automatically Retractable Safety Syringe (with Fixed Needle).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113587
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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