Cleared Traditional

SMB Luer lock disposable syringe (K231558) - FDA 510(k) Clearance

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

K231558 · Smb Corporation of India · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
227d
Days
Class 2
Risk

K231558 is an FDA 510(k) clearance for the SMB Luer lock disposable syringe. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Smb Corporation of India (Valsad, IN). The FDA issued a Cleared decision on January 12, 2024 after a review of 227 days - an extended review cycle.

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. 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 Smb Corporation of India devices

Submission Details

510(k) Number K231558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2023
Decision Date January 12, 2024
Days to Decision 227 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
98d slower than avg
Panel avg: 129d · This submission: 227d
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 Consultant

Alceon Medtech Consulting
Atonu Datta

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMF Syringe, Piston

All 243
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K231558.
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K234024 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Mar 2024
Insulin Syringe
K233794 · Spm Medicare Pvt. , Ltd. · Mar 2024
Medline Luer Lock Syringes
K230235 · Medline Industries, LP · Feb 2024
Insulin Syringe
K230061 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Nov 2023
NavaClick Injection System
K231877 · Lineage Biomedical, Inc. · Nov 2023
Revital Cady
K231519 · Revital Healthcare (Epz) Limited · Nov 2023