# K230959: VitreJect® Needle; OcuSafe® Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ocuject, LLC
- Decided: Sep 14, 2023 after 163 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K970370 (1997). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212805: SteriCap Mini Needle and Standard Needles, Ocuject, LLC (2021) Summary page 4.

## Most influential descendants
- K233343: SteriCap Safety Needle; VitreJect Safety Needle (2023), 1 descendant of its own
- K242956: LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle (2024), 0 descendants of its own

## Indications for use
The VitreJect® Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® Needle is indicated for intravitreal use. The OcuSafe® Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® Needle is indicated for intravitreal use.

Source page: https://510kreport.com/device/K230959
Methodology: https://510kreport.com/methodology