# K242956: LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle

- Pathway: 510(k) (Special)
- Applicant: Ocuject, LLC
- Decided: Oct 25, 2024 after 30 days
- Product code: QNS (Low Dead Space Needle, Single Lumen, Hypodermic)
- 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: 7 generations back to K970370 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233343: SteriCap Safety Needle; VitreJect Safety Needle, Ocuject, LLC (2023) Summary page 5.
- K230959: VitreJect® Needle; OcuSafe® Needle, Ocuject, LLC (2023) Summary page 5.
- K212805: SteriCap Mini Needle and Standard Needles, Ocuject, LLC (2021) Summary page 5.

## Indications for use
The LDS Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® LDS Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® LDS Needle is indicated for intravitreal use. The SteriCap® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick. The VitreJect® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® LDS Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick. The VitreJect® LDS Safety Needle is indicated for intravitreal use.

Source page: https://510kreport.com/device/K242956
Methodology: https://510kreport.com/methodology