510(k) · Cleared
ClearedSez Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sez Corporation · MEG Syringe, Antistick
Cleared on Jul 8, 2003 as substantially equivalent to K011754 (Exelint Intl. Co., 2003) after an 85-day review. Its family tree reaches back 1 generation to 2003. 4 later devices descend from it.
- Decided
- Jul 8, 2003
- Review
- 85 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011754 (2003). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK011754 Exel Securetouch PTP SyringeExelint Intl. Co. · 2003
- This deviceK031163 Sez Safety SyringeSez Corporation · 2003
- Descendant · cites it directly · 0 of its ownK070117 Ssafe Plus Disposable Safety Syringe, 3 CC and 5 CCDolomite Biotech Sdn Bhd · 2007
- Descendant · cites it directly · 0 of its ownK060109 Omi Retractable Safety SyringeVitalcare Group, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK050116 Uniqsafe Rotatable, Retractable Safety SyringesUniqsafe Biomeditech Co., Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK043419 P&P Safety SyringeMedexel Medical Mfg. Co., Ltd. · 2005
Most influential descendants
Showing 4 of 4 · See all- K070117Ssafe Plus Disposable Safety Syringe, 3 CC and 5 CCDolomite Biotech Sdn Bhd · 2007 · cites it directly0descendants
- K060109Omi Retractable Safety SyringeVitalcare Group, Inc. · 2006 · cites it directly0descendants
- K050116Uniqsafe Rotatable, Retractable Safety SyringesUniqsafe Biomeditech Co., Ltd. · 2005 · cites it directly0descendants
- K043419P&P Safety SyringeMedexel Medical Mfg. Co., Ltd. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011754 | Exel Securetouch PTP Syringe | Exelint Intl. Co. | 2003 | — |
| 0 (this device) | K031163 | Sez Safety Syringe | Sez Corporation | 2003 | — |
| +1 | K070117 | Ssafe Plus Disposable Safety Syringe, 3 CC and 5 CC | Dolomite Biotech Sdn Bhd | 2007 | — |
| +1 | K060109 | Omi Retractable Safety Syringe | Vitalcare Group, Inc. | 2006 | — |
| +1 | K050116 | Uniqsafe Rotatable, Retractable Safety Syringes | Uniqsafe Biomeditech Co., Ltd. | 2005 | — |
| +1 | K043419 | P&P Safety Syringe | Medexel Medical Mfg. Co., Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K011754 | Exel Securetouch PTP Syringe | 2003 |
What descends from it? (4)
4 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?
- Its one ancestor has no recall.
- Of its descendants, K070117 (Dolomite Biotech Sdn Bhd, 2007) has gone furthest, with 0 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?
This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of
medication to patients. This device aids in prevention of needlestick injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031163: Sez 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/K031163
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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