Atlas FDA

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

FDA 510(k) clearance K243660 · decided 2025-08-22

Clearance details

K-number
K243660
Device name
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
Applicant
Cardinalhealth
Decision
Substantially Equivalent
Date received
2024-11-27
Decision date
2025-08-22
Days to decision
268 days
Clearance type
Traditional
Product code
FMF
Device class
2
Regulation number
880.5860
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Waukegan, IL, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (K252279)Chirana T.Injecta,A.S.2026-04-17
Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (K253068)CMT Health PTE., Ltd.2026-02-23
Instylla Delivery Kit (K253769)Instylla, Inc.2025-12-22
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EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle (K251089)Exelint International, Co.2025-12-12
Verisafe Safety Retractable Insulin Syringes (K250192)Promisemed Hangzhou Meditech Co., Ltd.2025-12-10
Merit Syringe (K250853)Merit Medical Systems, Inc.2025-11-04
Sure-Fine Insulin Syringes (K250510)Shina Med Corporation2025-10-15

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Cardinal Health Multifunctional Defibrillation Electrode (P190007)Cardinalhealth2020-08-07