# K013006: Ovus Capless Safety Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ovus Systems
- Decided: Feb 6, 2002 after 153 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 K904198 (1990). 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)
- K946219: Pop-N-Lok Syringe, Retractable Technologies, Inc. (1995) Summary page 1.
- K904198: Safety Needle Sheath, Concord/Portex (1990) Summary page 1.
- K911037: Safety Needle Sheath, Modification, Concord/Portex (1991) Summary page 1.

## Indications for use
The OVUS Capless Safety Needle, when used with a standard commerdially available syringe, is intended to inject fluids into, or withdraw fluids from, parts of the body, including the applications of hypodermic injection, veinipuncture, and drawing of arterial blood. The needle is retracted after use to prevent further needle sticks.

Source page: https://510kreport.com/device/K013006
Methodology: https://510kreport.com/methodology