FDA.reportPublic FDA data

510(k) K231095

Device
Tamper Evident Cap
Applicant
International Medical Industries, Inc.
510(k) number
K231095
Product code
FMF
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-04
Date received
2023-04-18
Regulation
880.5860
Classification name
Syringe, Piston
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
David Meily
Address
2981 Gateway Dr. Pompano Beach FL US 33069 33069

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FMF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.2026-05-21
K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.2026-04-17
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K253769Instylla Delivery KitInstylla, Inc.2025-12-22
K252518DuoprossTM Smart Cap (Type I)Duopross Meditech Corporate2025-12-17
K251089EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic NeedleExelint International, Co.2025-12-12
K250192Verisafe Safety Retractable Insulin SyringesPromisemed Hangzhou Meditech Co., Ltd.2025-12-10
K250853Merit SyringeMerit Medical Systems, Inc.2025-11-04
K250510Sure-Fine Insulin SyringesShina Med Corporation2025-10-15
K243660Monoject™ 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); MonojecCardinalhealth2025-08-22
K251350BD Plastipak™ SyringeBecton, Dickinson and Company2025-07-29
K252033Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with NeedleCMT Health PTE., Ltd.2025-07-25
K2507333DOSE 1ml SyringeBimed Teknik Aletler Sanayi & Ticaret A.S.2025-07-03
K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.2025-06-24
K250262GO-PEN®Go-Pen Aps2025-04-24