Cleared Traditional

VitreJect® Needle (K230959) - FDA 510(k) Clearance

Also marketed or referenced as:
OcuSafe® Needle

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230959 · Ocuject, LLC · General Hospital
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Optimized for regulatory review, auditing and printing
Sep 2023
Decision
163d
Days
Class 2
Risk

K230959 is an FDA 510(k) clearance for the VitreJect® Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Ocuject, LLC (Newport Beach, US). The FDA issued a Cleared decision on September 14, 2023 after a review of 163 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ocuject, LLC devices

Submission Details

510(k) Number K230959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2023
Decision Date September 14, 2023
Days to Decision 163 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 129d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Namsa
Heidi Busz

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 196
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K230959.
SteriCap Safety Needle
K233343 · Ocuject, LLC · Nov 2023
MESORAM® Hypodermic Needle (710301)
K230070 · Promamedical, Inc. · Oct 2023
Insulin Pen Needle
K230043 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Sep 2023
Sterile Hypodermic Needles for Single Use
K231720 · Wepon Medical Technology Co., Ltd. · Sep 2023
Sterile Safety Hypodermic Needles for Single Use
K231723 · Wepon Medical Technology Co., Ltd. · Sep 2023
Sterile syringes for single use with/without needle
K231729 · Wepon Medical Technology Co., Ltd. · Sep 2023