Cleared Traditional

K243660 - Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777) (FDA 510(k) Clearance)

Also includes:
Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777) Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777) Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777) Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777) Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777) Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777) Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934) Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937) Monojec

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

K243660 · Cardinalhealth · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2025
Decision
268d
Days
Class 2
Risk

K243660 is an FDA 510(k) clearance for the Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on August 22, 2025 after a review of 268 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 Cardinalhealth devices

Submission Details

510(k) Number K243660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2024
Decision Date August 22, 2025
Days to Decision 268 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 128d · This submission: 268d
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

Cardinal Health200, LLC
Kyle Hooper

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 748
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