510(k) · Cleared
ClearedVanishpoint 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 Feb 12, 1998 after a 35-day review. The FDA summary names its predicate without a number. 22 later devices descend from it.
- Decided
- Feb 12, 1998
- Review
- 35 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 4 citing it directly.
- This deviceK980069 Vanishpoint SyringeRetractable Technologies, Inc. · 1998
- Descendant · cites it directly · 16 of its ownK023752 BD Integra SyringeBd · 2003 · Recalled
- Descendant · 2 generations on · 5 of its ownK132120 WTF Secura Syringe and NeedleBeijing Wantefu Medical Apparatus Co., Ltd. · 2013
- Descendant · 2 generations on · 4 of its ownK182274 Orbit Subretinal Delivery SystemOrbit Biomedical, Inc. · 2018
- Descendant · 3 generations on · 3 of its ownK200325 Orbit Subretinal Delivery SystemOrbit Biomedical · 2020
- Descendant · 3 generations on · 3 of its ownK143497 Safety Auto-Disable Syrine with Needle (Auto-Lock)Guangdong Intmed Medical Appliance Co., Ltd. · 2015
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K023752BD Integra SyringeBd · 2003 · cites it directly16descendants
- K132120WTF Secura Syringe and NeedleBeijing Wantefu Medical Apparatus Co., Ltd. · 2013 · 2 generations on5descendants
- K182274Orbit Subretinal Delivery SystemOrbit Biomedical, Inc. · 2018 · 2 generations on4descendants
- K200325Orbit Subretinal Delivery SystemOrbit Biomedical · 2020 · 3 generations on3descendants
- K143497Safety Auto-Disable Syrine with Needle (Auto-Lock)Guangdong Intmed Medical Appliance Co., Ltd. · 2015 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980069 | Vanishpoint Syringe | Retractable Technologies, Inc. | 1998 | — |
| +1 | K023752 | BD Integra Syringe | Bd | 2003 | 2 |
| +2 | K132120 | WTF Secura Syringe and Needle | Beijing Wantefu Medical Apparatus Co., Ltd. | 2013 | — |
| +2 | K182274 | Orbit Subretinal Delivery System | Orbit Biomedical, Inc. | 2018 | — |
| +3 | K200325 | Orbit Subretinal Delivery System | Orbit Biomedical | 2020 | — |
| +3 | K143497 | Safety Auto-Disable Syrine with Needle (Auto-Lock) | Guangdong Intmed Medical Appliance Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | — | Original 3 cc VanishPoint® Syringe Named without a submission number | |
| * | — | 5 cc and 10 cc VanishPoint® Syringes Named without a submission number | |
| * | — | 1 cc Allergy and Insulin Syringes Named without a submission number |
What descends from it? (22)
See all 224 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, K023752 (Bd, 2003) has gone furthest, with 16 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 summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980069 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980069: 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/K980069
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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