510(k) · Cleared
ClearedAnti-Stick Syringe with Integral Hypodermic Needle Vanishpoint Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Retractable Technologies, Inc. · MEG Syringe, Antistick
Cleared on May 29, 1997 after an 86-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- May 29, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK970803 Anti-Stick Syringe with Integral Hypodermic Needle Vanishpoint SyringeRetractable Technologies, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK113587 Automatically Retractable Safety Syringe (with Fixed Needle)Shantou Wealy Medical Instrument Co.,Ltd · 2012
- Descendant · 2 generations on · 1 of its ownK141640 Automatically Retractable Safety Syringes with Fixed NeedleShantou Wealy Medical Instrument Co.,Ltd · 2014
- Descendant · 3 generations on · 0 of its ownK222452 Disposable Automatically Retractable Safety Syringes (with…Shantou Wealy Medical Instrument Co.,Ltd · 2022
- Descendant · 2 generations on · 0 of its ownK141349 Disposable sterile needle retractable safety syringeGuangdong Haiou Medical Apparatus Stock Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK133635 Easypoint NeedleRetractable Technologies, Inc. · 2014 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K113587Automatically Retractable Safety Syringe (with Fixed Needle)Shantou Wealy Medical Instrument Co.,Ltd · 2012 · cites it directly3descendants
- K141640Automatically Retractable Safety Syringes with Fixed NeedleShantou Wealy Medical Instrument Co.,Ltd · 2014 · 2 generations on1descendant
- K222452Disposable Automatically Retractable Safety Syringes (with detachable needle)Shantou Wealy Medical Instrument Co.,Ltd · 2022 · 3 generations on0descendants
- K141349Disposable sterile needle retractable safety syringeGuangdong Haiou Medical Apparatus Stock Co., Ltd. · 2015 · 2 generations on0descendants
- K133635Easypoint NeedleRetractable Technologies, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K141640 | Automatically Retractable Safety Syringes with Fixed Needle | Shantou Wealy Medical Instrument Co.,Ltd | 2014 | — |
| +3 | K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle) | Shantou Wealy Medical Instrument Co.,Ltd | 2022 | — |
| +2 | K141349 | Disposable sterile needle retractable safety syringe | Guangdong Haiou Medical Apparatus Stock Co., Ltd. | 2015 | — |
| +1 | K133635 | Easypoint Needle | Retractable Technologies, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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.
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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
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?
- Of its descendants, K113587 (Shantou Wealy Medical Instrument Co.,Ltd, 2012) 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?
The function of the VanishPoint™ Syringe is to provide a safe and reliable method of injecting medication into a patient or withdrawing blood from a patient. The VanishPoint™ Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe barrel, the syringe user is protected from accidental needlesticks. These accidental needlesticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970803: Anti-Stick Syringe with Integral Hypodermic Needle Vanishpoint Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970803
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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