# K973888: Smartlock Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Medical Innovation, Ltd.
- Decided: Jun 3, 1998 after 232 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Plastipak standard syringe: named in the summary without a submission number
- (no number) Becton Dickinson Safety-Lok safety syringe: named in the summary without a submission number

## Indications for use
A sterile, single-use hypodermic syringe, incorporating a safety mechanism designed to withdraw the needle back into the safety shield after use and lock it in this position. To be used for injecting medications or fluid into the patient by attached cannula or via IV therapy or to draw samples or fluids by the same means.

Source page: https://510kreport.com/device/K973888
Methodology: https://510kreport.com/methodology