# K093176: Med-Lok

- Pathway: 510(k) (Traditional)
- Applicant: Sta-Med, LLC
- Decided: Apr 6, 2010 after 180 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: 5 generations back to K904198 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063755: Portex Hypodermic Needle-Pro Fixed Needle Syringe, Smiths Medical Asd, Inc. (2007)

## Indications for use
The Med-Lok TM Safety Needle Device is intended for aspirations and injections of fluids. The needle protection device covers the needle after use to help prevent needle sticks.

Source page: https://510kreport.com/device/K093176
Methodology: https://510kreport.com/methodology