Cleared Traditional

Monoject? 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); 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

K243660 · Cardinalhealth · General Hospital

Aug 2025

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K243660 is an FDA 510(k) clearance for the Monoject? 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); 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, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on August 22, 2025, 268 days after receiving the submission on November 27, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K243660 FDA.gov
FDA Decision	Cleared 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