# K060109: Omi Retractable Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Vitalcare Group, Inc.
- Decided: May 5, 2006 after 112 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: 2 generations back to K011754 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031163: Sez Safety Syringe, Sez Corporation (2003) Summary page 1.

## Indications for use
This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EQ sterilized, non-pyrogenic, and latex free.

Source page: https://510kreport.com/device/K060109
Methodology: https://510kreport.com/methodology