Cleared Traditional

K170768 - Mini Needle

K170768 is an FDA 510(k) clearance for Mini Needle, manufactured by Ocuject, LLC. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K170768 · Ocuject, LLC · General Hospital
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Jul 2017
Decision
118d
Days
Class 2
Risk

K170768 is an FDA 510(k) clearance for the Mini 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 July 10, 2017 after a review of 118 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K170768

510(k) Number K170768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2017
Decision Date July 10, 2017
Days to Decision 118 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
11d faster than avg
Panel avg: 129d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

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 Peers - FMI Needle, Hypodermic, Single Lumen

All 532
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K170768.
Safety Blood Collection Device for Single Use
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Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
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Safety Blood Collection Set
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