# K060971: Omi Retractable Saftey Syringe, Various

- Pathway: 510(k) (Traditional)
- Applicant: Omi Manufacturing Pty., Ltd.
- Decided: Oct 24, 2006 after 200 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 OMI Safety Insulin Syringes are intended for the subcutaneous injection of insulin. In addition, the syringe is designed to aid in prevention of needlestick injuries. This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, and latex free.

Source page: https://510kreport.com/device/K060971
Methodology: https://510kreport.com/methodology