Cleared Traditional

K230718 - UTC 3mL Medication Cartridge

K230718 is an FDA 510(k) clearance for UTC 3mL Medication Cartridge, manufactured by Gilero, LLC. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K230718 · Gilero, LLC · General Hospital
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Jun 2023
Decision
92d
Days
Class 2
Risk

K230718 is an FDA 510(k) clearance for the UTC 3mL Medication Cartridge. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Gilero, LLC (Morrisville, US). The FDA issued a Cleared decision on June 15, 2023 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Gilero, LLC devices

FDA 510(k) Submission Details - K230718

510(k) Number K230718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2023
Decision Date June 15, 2023
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRZ Device Classification - Class 2, Special Controls

Product Code MRZ Accessories, Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - MRZ Accessories, Pump, Infusion

All 17
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K230718.
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