# K243660: 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

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Aug 22, 2025 after 268 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Monoject Syringes with Luer tip are intended for single use by health care professionals for general purpose fluid aspiration and/or injection.

Source page: https://510kreport.com/device/K243660
Methodology: https://510kreport.com/methodology