Cleared Traditional

MiniLoad Syringe (K202432) - FDA 510(k) Clearance

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

K202432 · Ocuject, LLC · General Hospital
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Feb 2021
Decision
178d
Days
Class 2
Risk

K202432 is an FDA 510(k) clearance for the MiniLoad Syringe. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Ocuject, LLC (Newport Beach, US). The FDA issued a Cleared decision on February 19, 2021 after a review of 178 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 K202432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2020
Decision Date February 19, 2021
Days to Decision 178 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
49d slower than avg
Panel avg: 129d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 Peers - FMF Syringe, Piston

All 239
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K202432.
SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX
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1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock
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MicroDose Injector
K203264 · Medone Surgical, Inc. · Apr 2021
BD Hypodermic Syringe
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Nanum Syringe
K201930 · Nanum Company Co., Ltd. · Jan 2021
Instylla Delivery Kit
K202544 · Instylla, Inc. · Jan 2021