510(k) · Cleared
ClearedSyringex Safety Syringe, Model 0322G1.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syringex Medical, Inc. · MEG Syringe, Antistick
Cleared on Jun 23, 2003 as substantially equivalent to K925039 (U.S. Medical Instruments, Inc., 1994) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jun 23, 2003
- Review
- 81 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910520 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK910520 Safetysnap Safety SyringeU.S. Medical Instruments, Inc. · 1991
- This deviceK031065 Syringex Safety Syringe, Model 0322G1.5Syringex Medical, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910520 | Safetysnap Safety Syringe | U.S. Medical Instruments, Inc. | 1991 | — |
| 0 (this device) | K031065 | Syringex Safety Syringe, Model 0322G1.5 | Syringex Medical, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (2)
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 |
|---|---|---|---|
| * | K925039 | Safesnap Safety SyringeSummary page 1…d device to which we claim equivalence: SafeSnap Retractable Needle Syringe U S . Medical Instruments, Inc. San Diego, CA 92 127 510(k) Number K925039, K9 10520 Description of device The Syringex Safety Syringe@ is a retractable needle safety syringe. The syringe design employs… | 1994 |
| * | K910520 | Safetysnap Safety SyringeSummary page 1…to which we claim equivalence: SafeSnap Retractable Needle Syringe U S . Medical Instruments, Inc. San Diego, CA 92 127 510(k) Number K925039, K9 10520 Description of device The Syringex Safety Syringe@ is a retractable needle safety syringe. The syringe design employs a retract… | 1991 |
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?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K925039.
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 primary intended use of the Syringex Safety SyringeO is “a hypodermic needle and syringe intended to inject fluid into or withdraw fluid from the body”.
The secondary intended use is that the sharps safety feature will help to reduce the number of sharps injuries by providing an immediate and mandatory elimination of the sharp by its safe, simple and easy retraction into the barrel of the syringe. The feature will help prevent sharps injuries when using the device for its primary intended use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031065: Syringex Safety Syringe, Model 0322G1.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031065
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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