Cleared Traditional

K230235 - Medline Luer Lock Syringes

K230235 is an FDA 510(k) clearance for Medline Luer Lock Syringes, manufactured by Medline Industries, LP. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K230235 · Medline Industries, LP · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K230235

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
256d slower than avg
Panel avg: 129d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

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 480
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K230235.
Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
K232950 · Perfect Medical Industry (Vn) Co., Ltd. · Jun 2024
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K234024 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Mar 2024
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K233794 · Spm Medicare Pvt. , Ltd. · Mar 2024
SMB Luer lock disposable syringe
K231558 · Smb Corporation of India · Jan 2024
Insulin Syringe
K230061 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Nov 2023
NavaClick Injection System
K231877 · Lineage Biomedical, Inc. · Nov 2023