# K032517: Medsafe Clicksafe Safety Antistick Syringe with Hypodermic Needle

- Pathway: 510(k) (Abbreviated)
- Applicant: Medsafe Technologies, LLC
- Decided: May 18, 2004 after 278 days
- Product code: MEG (Syringe, Antistick)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K946219 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946219: Pop-N-Lok Syringe, Retractable Technologies, Inc. (1995) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K032517
Methodology: https://510kreport.com/methodology