Ocuject, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Ocuject, LLC” (first 2017, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 166 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 118 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 3 | 62 |
| 2022 | 0 | — |
| 2023 | 3 | 163 |
| 2024 | 1 | 30 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ocuject, LLC took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 166 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 4 | 4 |
| FMF | Syringe, Piston | 2 | 2 |
| QLY | Ophthalmic Syringe | 1 | 1 |
| QNS | Low Dead Space Needle, Single Lumen, Hypodermic | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Ocuject, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242956 | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle | QNS | 2024-10-25 | 30 |
| K233343 | SteriCap Safety Needle; VitreJect Safety Needle | FMI | 2023-11-27 | 59 |
| K230959 | VitreJect® Needle; OcuSafe® Needle | FMI | 2023-09-14 | 163 |
| K230372 | VitreJect Syringe | QLY | 2023-09-08 | 207 |
| K212544 | MiniLoad Syringe | FMF | 2021-10-13 | 62 |
| K212805 | SteriCap Mini Needle and Standard Needles | FMI | 2021-09-30 | 28 |
| K202432 | MiniLoad Syringe | FMF | 2021-02-19 | 178 |
| K170768 | Mini Needle | FMI | 2017-07-10 | 118 |
Recalls
openFDA lists no recalls under a recalling firm named Ocuject, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ocuject, LLC?
FDA lists 8 510(k) clearances under the applicant name “Ocuject, LLC” (first 2017, latest 2024), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ocuject, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ocuject, LLC is 90 days. Since 2017: 90 days, versus 166 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ocuject, LLC?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 4); FMF (Syringe, Piston, 2); QLY (Ophthalmic Syringe, 1).
Next steps
- See all 8 Ocuject, LLC clearances with predicates and recalls
- Run predicate analysis for product code FMI, Ocuject, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.