510(k) · Cleared
ClearedMedsafe Clicksafe Safety Antistick Syringe with Hypodermic Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medsafe Technologies, LLC · MEG Syringe, Antistick
Cleared on May 18, 2004 as substantially equivalent to K946219 (Retractable Technologies, Inc., 1995) after a 278-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- May 18, 2004
- Review
- 278 days
- Class
- Class II
- Product code
- MEG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946219 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK946219 Pop-N-Lok SyringeRetractable Technologies, Inc. · 1995
- This deviceK032517 Medsafe Clicksafe Safety Antistick Syringe with Hypodermic NeedleMedsafe Technologies, LLC · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946219 | Pop-N-Lok Syringe | Retractable Technologies, Inc. | 1995 | — |
| 0 (this device) | K032517 | Medsafe Clicksafe Safety Antistick Syringe with Hypodermic Needle | Medsafe Technologies, LLC | 2004 | — |
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 |
|---|---|---|---|
| * | K946219 | Pop-N-Lok SyringeSummary page 1…hypodermic needle 10O-Substantial Equivalency is claimed against the following device: *VANISHPOINT SYRINGE from RETRACTABLE TECHNOLOGIES, INC. 5 10k# K946219, cleared at that time under the tradename of Pop-N-Lok syringe. 11-Description of the Device: The MedSafe ClickSafe TM… | 1995 |
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K946219.
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 MedSafe ClickSafeTM syringe is a 3cc sterile, non-toxic, non-pyrogenic, disposable, manually activated, plunger type, anti-stick syringe with integral hypodermic needle. Its primary intended use and indication for use is to provide safe, accurate and reliable method of injecting medication into a patient, subcutaneous as well as intramuscular. Needle retraction is activated by the syringe user after removing the needle from the patient first. Its…
Read the full statement (132 words)
The MedSafe ClickSafeTM syringe is a 3cc sterile, non-toxic, non-pyrogenic, disposable, manually activated, plunger type, anti-stick syringe with integral hypodermic needle.
Its primary intended use and indication for use is to provide safe, accurate and reliable method of injecting medication into a patient, subcutaneous as well as intramuscular. Needle retraction is activated by the syringe user after removing the needle from the patient first.
Its secondary intended use and indication for use is to retract and contain the contaminated needle after injection and render the syringe inoperable for further injections while not introducing any additional steps to the one-handed operation method, for the purpose of aiding in the prevention of accidental needle stick injuries that would be occurring between removing the needle from the patient and disposing it into the Sharps 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/K032517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032517: Medsafe Clicksafe Safety Antistick Syringe with Hypodermic Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032517
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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