510(k) · Cleared
ClearedLDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ocuject, LLC · QNS Low Dead Space Needle, Single Lumen, Hypodermic
Cleared on Oct 25, 2024 as substantially equivalent to K233343 (Ocuject, LLC, 2023) and 2 other predicates after a 30-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Oct 25, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- QNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K970370 (1997). No later device cites it as a predicate yet.
- Root · 7 generations backK970370 TSK Sterijekt Premium Disposable Hypodermic NeedleTsk Laboratory, Japan · 1997 · Recalled
- 6 generations backK151571 Mini NeedleOcujet, LLC · 2015
- 5 generations backK170768 Mini NeedleOcuject, LLC · 2017
- 4 generations backK183016 SteriCap Mini NeedleOcujet, LLC · 2019
- 3 generations backK212805 SteriCap Mini Needle and Standard NeedlesOcuject, LLC · 2021
- 2 generations backK230959 VitreJect® Needle; OcuSafe® NeedleOcuject, LLC · 2023
- 1 generation backK233343 SteriCap Safety Needle; VitreJect Safety NeedleOcuject, LLC · 2023
- This deviceK242956 LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle…Ocuject, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970370 | TSK Sterijekt Premium Disposable Hypodermic Needle | Tsk Laboratory, Japan | 1997 | 1 |
| −6 | K151571 | Mini Needle | Ocujet, LLC | 2015 | — |
| −5 | K170768 | Mini Needle | Ocuject, LLC | 2017 | — |
| −4 | K183016 | SteriCap Mini Needle | Ocujet, LLC | 2019 | — |
| −3 | K212805 | SteriCap Mini Needle and Standard Needles | Ocuject, LLC | 2021 | — |
| −2 | K230959 | VitreJect® Needle; OcuSafe® Needle | Ocuject, LLC | 2023 | — |
| −1 | K233343 | SteriCap Safety Needle; VitreJect Safety Needle | Ocuject, LLC | 2023 | — |
| 0 (this device) | K242956 | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS… | Ocuject, LLC | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QNS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QNS device
- #1 K210444 EZ-Injec LDV Sterile Safety Needlescore 17.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K233343 | SteriCap Safety Needle; VitreJect Safety NeedleSummary page 5…: II Product Code(s): QNS, FMI, QYM Legally Marketed Predicate Device: Predicate Devices: SteriCap® Safety Needle / VitreJect® Safety Needle, 510(k) # K233343 VitreJect® Needle / OcuSafe® Needle, 510(k) # K230959 SteriCap™ Mini Needle and Standar… | 2023 |
| * | K230959 | VitreJect® Needle; OcuSafe® NeedleSummary page 5…cate Device: Predicate Devices: SteriCap® Safety Needle / VitreJect® Safety Needle, 510(k) # K233343 VitreJect® Needle / OcuSafe® Needle, 510(k) # K230959 SteriCap™ Mini Needle and Standard Needles, 510(k) # K212805 Reference Predicate Device: EZ-Injec LDV Ster… | 2023 |
| * | K212805 | SteriCap Mini Needle and Standard NeedlesSummary page 5…le, 510(k) # K233343 VitreJect® Needle / OcuSafe® Needle, 510(k) # K230959 SteriCap™ Mini Needle and Standard Needles, 510(k) # K212805 Reference Predicate Device: EZ-Injec LDV Sterile Safety Needle, 510(k) # K210444 Device Description: The LDS Needle / OcuSaf… | 2021 |
| † | K210444 | EZ-Injec LDV Sterile Safety Needle | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All QNS devicesQNS Low Dead Space Needle, Single Lumen, Hypodermic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QNS
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QNS
Too few QNS 510(k)s in any year since 2007 to give a median.
Recalls per year · QNS
No recall names QNS since 2007.
Adverse event reports per year · QNS
No MAUDE report names QNS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (187 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242956 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242956: LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242956
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026