# K170768: Mini Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ocuject, LLC
- Decided: Jul 10, 2017 after 118 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: 2 generations back to K970370 (1997). 2 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K151571: Mini Needle, Ocujet, LLC (2015) Summary page 4.

## Most influential descendants
- K183016: SteriCap Mini Needle (2019), 4 descendants of its own
- K212805: SteriCap Mini Needle and Standard Needles (2021), 3 descendants of its own
- K230959: VitreJect® Needle; OcuSafe® Needle (2023), 2 descendants of its own
- 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 Mini Needle is intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs

Source page: https://510kreport.com/device/K170768
Methodology: https://510kreport.com/methodology