Cleared Traditional

K230235 - Medline Luer Lock Syringes

K230235 is the FDA 510(k) clearance for Medline Luer Lock Syringes by Medline Industries, LP. It is a Class 2 General Hospital device (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

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
256d slower than avg
Panel avg: 129d · 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.

Regulatory Peers - FMF Syringe, Piston

All 285
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
HWJECT Auto-disable syringe
K234024 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Mar 2024
Insulin Syringe
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