510(k) K253112

Device: Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
Applicant: Hlb Lifescience Co., Ltd.
510(k) number: K253112
Product code: FMF
Decision: Substantially Equivalent (SESE)
Decision date: 2026-05-21
Date received: 2025-09-24
Regulation: 880.5860
Classification name: Syringe, Piston
Medical specialty: General Hospital
Review panel: General Hospital
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Jiwon Han
Address: 122-39, Gieopdanji-Ro, Gongdo-Eup Anseong-Si KR 17551 17551

FDA Registration Numbers

1423537
3013576619
3016685880
3023851856
1063851
3012187743
3005064037
1000484830
8041145
3009761558
3034669683
1819470
3008812241
8031563
3013404959
3014747754
8040700
3009551627
3013700547
2517117
3005862821
2320767
2183771
3003974574
3015997711
3010400367
1018120
8040619
1047843
2032521
3004054016
2433012
1054241
3008868758
2245304
1928237
3006380458
2650089
3004192065
9612057
1410248
3029755538
1219930
9681835
3010120148
1721183
9610847
3004024955
9610825
9681821
1220477
1019003
3031788372
3014570560
3009417901
3010864832
1450743
3022699058
2243072
3007344957
3010221586
1036836
3009337401
3011230048
1213809
3010377171
1417485
9612030
1061124
3012187635
3036722184
3016733629
3015724777
3007193283
1226146
3015967359
3012410077
3017509841
1017768

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FMF

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K252279	Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)	Chirana T.Injecta,A.S.	2026-04-17
K253068	Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe	CMT Health PTE., Ltd.	2026-02-23
K253769	Instylla Delivery Kit	Instylla, Inc.	2025-12-22
K252518	DuoprossTM Smart Cap (Type I)	Duopross Meditech Corporate	2025-12-17
K251089	EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle	Exelint International, Co.	2025-12-12
K250192	Verisafe Safety Retractable Insulin Syringes	Promisemed Hangzhou Meditech Co., Ltd.	2025-12-10
K250853	Merit Syringe	Merit Medical Systems, Inc.	2025-11-04
K250510	Sure-Fine Insulin Syringes	Shina Med Corporation	2025-10-15
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	Cardinalhealth	2025-08-22
K251350	BD Plastipak Syringe	Becton, Dickinson and Company	2025-07-29
K252033	Profoject Disposable Syringe, Profoject Disposable Syringe with Needle	CMT Health PTE., Ltd.	2025-07-25
K250733	3DOSE 1ml Syringe	Bimed Teknik Aletler Sanayi & Ticaret A.S.	2025-07-03
K251648	GPS Advanced; GPS Advanced Cannula	Prosidyan, Inc.	2025-06-24
K250262	GO-PEN®	Go-Pen Aps	2025-04-24
K243580	GraftGun Universal Graft Delivery System (GDS)	SurGenTec, LLC	2025-02-05