# K162030: 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle

- Pathway: 510(k) (Special)
- Applicant: Sol-Millennium Medical, Inc.
- Decided: Aug 19, 2016 after 28 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: 3 generations back to K941450 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092430: 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock Safety Syringes, Inviro Medical Devices, Inc. (2009) Summary page 4.

## Indications for use
The 0.5ml Sol-Care™ Retractable Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the 0.5ml Sol-Care™ Retractable Safety Syringes is designed to aid in the prevention of needle stick injuries.

Source page: https://510kreport.com/device/K162030
Methodology: https://510kreport.com/methodology