510(k) · Cleared
ClearedClickzip Needle Retractable Safety Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Device Manufacturer (Thailand), Ltd. · MEG Syringe, Antistick
Cleared on Dec 21, 2005 as substantially equivalent to K012121 (Safegard Medical Products, Inc., 2001) after a 181-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Dec 21, 2005
- Review
- 181 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012121 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK012121 Secureguard Retractable Safety SyringeSafegard Medical Products, Inc. · 2001 · Recalled
- This deviceK051694 Clickzip Needle Retractable Safety SyringeMedical Device Manufacturer (Thailand), Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK062780 Clickzip, Model U-100 Insulin Safety SyringeMedical Device Manufacturer (Thailand), Ltd. · 2007
Most influential descendants
Showing 1 of 1 · See all- K062780Clickzip, Model U-100 Insulin Safety SyringeMedical Device Manufacturer (Thailand), Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012121 | Secureguard Retractable Safety Syringe | Safegard Medical Products, Inc. | 2001 | 1 |
| 0 (this device) | K051694 | Clickzip Needle Retractable Safety Syringe | Medical Device Manufacturer (Thailand), Ltd. | 2005 | — |
| +1 | K062780 | Clickzip, Model U-100 Insulin Safety Syringe | Medical Device Manufacturer (Thailand), Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K012121 | Secureguard Retractable Safety SyringeSummary page 2…ALENCE Medical Device Manufacturer (Thailand) Ltd. makes a claim of substantial equivalence of the SECUREGARDR Retractable Safety Syringe with 510(K) number K012121 based on similarities in intended use, design, technological and operational characteristics. Both are indicated for… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062780 | Clickzip, Model U-100 Insulin Safety Syringe | 2007 | 0 |
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?
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 ClickZip M Needle Retractable Safety Syringe is to be used for intra-muscular or subcutaneous injection of medications into a patient and is intended to prevent needle stick injuries. It is currently available in I ml, 3m1 and 5ml sizes. ClickZip Needle Retractable Safety Syringe is not intended to be used for withdrawing blood. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051694: Clickzip Needle Retractable 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/K051694
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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