# K212805: SteriCap Mini Needle and Standard Needles

- Pathway: 510(k) (Special)
- Applicant: Ocuject, LLC
- Decided: Sep 30, 2021 after 28 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: 4 generations back to K970370 (1997). 4 ancestors in all.
3 later devices descend from it; 3 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)
- K183016: SteriCap Mini Needle, Ocujet, LLC (2019) Summary page 4.

## Most influential descendants
- 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 SteriCap™ Mini Needle and standard needles are 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/K212805
Methodology: https://510kreport.com/methodology