# Ocuject, LLC

- Location (FDA's records): Newport Beach, CA
- FDA decisions: 8 (2017–2024): 8 510(k) clearances
- Product codes: FMI (4), FMF (2), QLY (1), QNS (1)
- 510(k) review time since 2016: median 90 days, against 159 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 11 (7 its own); citations of its devices by later devices: 9 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ocujet, LLC: 2 (https://510kreport.com/company/ocujet)
- Tribofilm Research, Inc.: 1 (https://510kreport.com/company/tribofilm-research)
- Henke-Sass, Wolf GmbH: 1 (https://510kreport.com/company/henke-sass-wolf)

## Firms that cite its devices most
- Smb Corporation of India: 1 (https://510kreport.com/company/smb-of-india)
- Ocujet, LLC: 1 (https://510kreport.com/company/ocujet)

## Its most-cited devices
- K212805: SteriCap Mini Needle and Standard Needles (2021), cited by 3
- K230959: VitreJect® Needle; OcuSafe® Needle (2023), cited by 2
- K202432: MiniLoad Syringe (2021), cited by 2
- K233343: SteriCap Safety Needle; VitreJect Safety Needle (2023), cited by 1
- K170768: Mini Needle (2017), cited by 1

## Recent decisions
- K242956: LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle (Oct 25, 2024)
- K233343: SteriCap Safety Needle; VitreJect Safety Needle (Nov 27, 2023)
- K230959: VitreJect® Needle; OcuSafe® Needle (Sep 14, 2023)
- K230372: VitreJect Syringe (Sep 8, 2023)
- K212544: MiniLoad Syringe (Oct 13, 2021)
- K212805: SteriCap Mini Needle and Standard Needles (Sep 30, 2021)
- K202432: MiniLoad Syringe (Feb 19, 2021)
- K170768: Mini Needle (Jul 10, 2017)

Source page: https://510kreport.com/company/ocuject