510(k) · Cleared
ClearedExel Securetouch PTP Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exelint Intl. Co. · MEG Syringe, Antistick
Cleared on Jan 22, 2003 after a 595-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jan 22, 2003
- Review
- 595 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK011754 Exel Securetouch PTP SyringeExelint Intl. Co. · 2003
- Descendant · cites it directly · 4 of its ownK031163 Sez Safety SyringeSez Corporation · 2003
- Descendant · 2 generations on · 0 of its ownK070117 Ssafe Plus Disposable Safety Syringe, 3 CC and 5 CCDolomite Biotech Sdn Bhd · 2007
- Descendant · 2 generations on · 0 of its ownK060109 Omi Retractable Safety SyringeVitalcare Group, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK050116 Uniqsafe Rotatable, Retractable Safety SyringesUniqsafe Biomeditech Co., Ltd. · 2005
- Descendant · 2 generations on · 0 of its ownK043419 P&P Safety SyringeMedexel Medical Mfg. Co., Ltd. · 2005
Most influential descendants
Showing 5 of 5 · See all- K031163Sez Safety SyringeSez Corporation · 2003 · cites it directly4descendants
- K070117Ssafe Plus Disposable Safety Syringe, 3 CC and 5 CCDolomite Biotech Sdn Bhd · 2007 · 2 generations on0descendants
- K060109Omi Retractable Safety SyringeVitalcare Group, Inc. · 2006 · 2 generations on0descendants
- K050116Uniqsafe Rotatable, Retractable Safety SyringesUniqsafe Biomeditech Co., Ltd. · 2005 · 2 generations on0descendants
- K043419P&P Safety SyringeMedexel Medical Mfg. Co., Ltd. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011754 | Exel Securetouch PTP Syringe | Exelint Intl. Co. | 2003 | — |
| +1 | K031163 | Sez Safety Syringe | Sez Corporation | 2003 | — |
| +2 | K070117 | Ssafe Plus Disposable Safety Syringe, 3 CC and 5 CC | Dolomite Biotech Sdn Bhd | 2007 | — |
| +2 | K060109 | Omi Retractable Safety Syringe | Vitalcare Group, Inc. | 2006 | — |
| +2 | K050116 | Uniqsafe Rotatable, Retractable Safety Syringes | Uniqsafe Biomeditech Co., Ltd. | 2005 | — |
| +2 | K043419 | P&P Safety Syringe | Medexel Medical Mfg. Co., Ltd. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031163 | Sez Safety Syringe | 2003 | 4 |
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, K031163 (Sez Corporation, 2003) has gone furthest, with 4 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 INJECTION OF MEDICATION TO PATIENTS.
=THIS DEVICE AIDS IN PREVENTION OF NEEDLE STICK INJURIES=
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K011754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011754: Exel Securetouch PTP Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011754
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026