Cleared Traditional

K230235 - Medline Luer Lock Syringes (FDA 510(k) Clearance)

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

K230235 · Medline Industries, LP · General Hospital

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Feb 2024

Decision

385d

Days

Class 2

Risk

K230235 is an FDA 510(k) clearance for the Medline Luer Lock Syringes. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medline Industries, LP (Northfiled, US). The FDA issued a Cleared decision on February 16, 2024 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medline Industries, LP devices

Submission Details

510(k) Number	K230235 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 27, 2023
Decision Date	February 16, 2024
Days to Decision	385 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

257d slower than avg

Panel avg: 128d · This submission: 385d

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.