Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Ocuject, LLC — Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

118 daysmedian FDA review time
207 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242956LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety NeedleOcuject, LLC2024-10-25300
K233343SteriCap Safety Needle; VitreJect Safety NeedleOcuject, LLC2023-11-27590
K230959VitreJect® Needle; OcuSafe® NeedleOcuject, LLC2023-09-141630
K230372VitreJect SyringeOcuject, LLC2023-09-082070
K212544MiniLoad SyringeOcuject, LLC2021-10-13620
K212805SteriCap Mini Needle and Standard NeedlesOcuject, LLC2021-09-30280
K202432MiniLoad SyringeOcuject, LLC2021-02-191780
K170768Mini NeedleOcuject, LLC2017-07-101180

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda