510(k) · Cleared
ClearedSteriCap Safety Needle; VitreJect Safety Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ocuject, LLC · FMI Needle, Hypodermic, Single Lumen
Cleared on Nov 27, 2023 as substantially equivalent to K212805 (Ocuject, LLC, 2021) and 1 other predicate after a 59-day review. Its family tree reaches back 6 generations to 1997. 1 later device descends from it.
- Decided
- Nov 27, 2023
- Review
- 59 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K970370 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK970370 TSK Sterijekt Premium Disposable Hypodermic NeedleTsk Laboratory, Japan · 1997 · Recalled
- 5 generations backK151571 Mini NeedleOcujet, LLC · 2015
- 4 generations backK170768 Mini NeedleOcuject, LLC · 2017
- 3 generations backK183016 SteriCap Mini NeedleOcujet, LLC · 2019
- 2 generations backK212805 SteriCap Mini Needle and Standard NeedlesOcuject, LLC · 2021
- 1 generation backK230959 VitreJect® Needle; OcuSafe® NeedleOcuject, LLC · 2023
- This deviceK233343 SteriCap Safety Needle; VitreJect Safety NeedleOcuject, LLC · 2023
- Descendant · cites it directly · 0 of its ownK242956 LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle…Ocuject, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K242956LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety NeedleOcuject, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K970370 | TSK Sterijekt Premium Disposable Hypodermic Needle | Tsk Laboratory, Japan | 1997 | 1 |
| −5 | K151571 | Mini Needle | Ocujet, LLC | 2015 | — |
| −4 | K170768 | Mini Needle | Ocuject, LLC | 2017 | — |
| −3 | K183016 | SteriCap Mini Needle | Ocujet, LLC | 2019 | — |
| −2 | K212805 | SteriCap Mini Needle and Standard Needles | Ocuject, LLC | 2021 | — |
| −1 | K230959 | VitreJect® Needle; OcuSafe® Needle | Ocuject, LLC | 2023 | — |
| 0 (this device) | K233343 | SteriCap Safety Needle; VitreJect Safety Needle | Ocuject, LLC | 2023 | — |
| +1 | K242956 | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS… | Ocuject, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K212805 | SteriCap Mini Needle and Standard NeedlesSummary page 4…n Name: Needle, Hypodermic, Single Lumen (21 CFR 880.5570) Regulatory Class: II Product Code: FMI III. PREDICATE DEVICE SteriCap® Mini Needle, K212805 VitreJect® Needle, K230959 The predicate devices have not been subject to design-related recall. IV. DEVICE DESCRIPTION SteriC… | 2021 |
| * | K230959 | VitreJect® Needle; OcuSafe® NeedleSummary page 4…mic, Single Lumen (21 CFR 880.5570) Regulatory Class: II Product Code: FMI III. PREDICATE DEVICE SteriCap® Mini Needle, K212805 VitreJect® Needle, K230959 The predicate devices have not been subject to design-related recall. IV. DEVICE DESCRIPTION SteriCap Safety Needle The SteriC… | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242956 | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle | 2024 | 0 |
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 26 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K242956 (Ocuject, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K212805.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The SteriCap 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 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 shield. The locked needle shield minimizes risk of accidental needle stick. The VitreJect Safety Needle is…
Read the full statement (141 words)
The SteriCap 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 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 shield. The locked needle shield minimizes risk of accidental needle stick.
The VitreJect Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect Safety Needle is indicated for intravitreal use.
The VitreJect Safety Needle has an integrated passive needle 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 shield. The locked needle shield minimizes risk of accidental needle stick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233343 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233343: SteriCap Safety Needle; VitreJect Safety Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233343
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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