Cleared Special

MiniLoad Syringe (K212544) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K212544 · Ocuject, LLC · General Hospital
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Oct 2021
Decision
62d
Days
Class 2
Risk

K212544 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 October 13, 2021 after a review of 62 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ocuject, LLC devices

Submission Details

510(k) Number K212544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2021
Decision Date October 13, 2021
Days to Decision 62 days
Submission Type Special
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
67d faster than avg
Panel avg: 129d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

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 K212544.
Disposable Syringe with Needle
K211482 · Shandong Qinkai Medical Industry Co., Ltd. · Jan 2022
CHIRANA Insulin Syringes
K201044 · Chirana T. Injecta · Jan 2022
Sterile Syringe for Single Use
K210914 · Jiangsu Suyun Medical Material Co., Ltd. · Dec 2021
Sterile syringes for single use with/without needle
K211211 · Azur Medical Company, Inc. · Oct 2021
Sterile hypodermic syringes for single use
K211728 · Jiangsu Kangyou Medical Instrument Co., Ltd. · Oct 2021
TrueCare Biomedix Tamper Evident Cap
K210818 · Us Infusion Inc. D/B/A Truecare Biomedix-USA · Sep 2021