510(k) Report

Devices descending from K980069

22 later devices reach Vanishpoint Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191490Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety…Jiangsu Caina Medical Co.,Ltd20190—
+1K051800IN6 Safety Syringe, Model 3MLIn6 Incuvestor, Inc.20052—
+1K042487Procedur SF Safety Syringe DeviceAvanca Medical Devices, Inc.20050—
+1K023752BD Integra SyringeBd2003162
+2K220114PowerPAK SyringeVault Paragon Group, Inc.20231—
+2K182274Orbit Subretinal Delivery SystemOrbit Biomedical, Inc.20184—
+2K132120WTF Secura Syringe and NeedleBeijing Wantefu Medical Apparatus Co., Ltd.20135—
+2K111734Mysafety SyringeMedicalchain Intl. Corp.20111—
+2K1009981ML Unitract 27G X 1/2 Tuberculin Syringe, Model 132BY2-1Unilife Medical Solutions Limited20100—
+2K0808771ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2Unilife Medical Solutions Limited20082—
+3K250847VaporShieldVault Paragon Group, Inc.20250—
+3K221981SafeR Syringe and SafeR StingRoncadelle Operations Srl20220—
+3K200325Orbit Subretinal Delivery SystemOrbit Biomedical20203—
+3K143497Safety Auto-Disable Syrine with Needle (Auto-Lock)Guangdong Intmed Medical Appliance Co., Ltd.20153—
+3K113673Mysafety SyringeMedicalchain Internartional Corporation20120—
+3K0934001ML Unitract Insulin Syringe 27G X 1/2 and 29G X 1/2Unilife Medical Solutions Limited20101—
+4K231727Sterile Auto-Disable Syringes with/without Needle for Single UseWepon Medical Technology Co., Ltd.20230—
+4K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)202216
+4K210229Sterile Auto-Disable Syringes with/without Needle for Single UseZhejiang Kangkang Medical-Devices Co., Ltd.20220—
+4K211210Sterile Auto-Disable Syringes with/without Needle for Single UseAzur Medical Company, Inc.20220—
+4K203264MicroDose InjectorMedone Surgical, Inc.20212—
+5K250501System SophiThis AG20250—