510(k) Report

Devices descending from K023752

16 later devices reach BD Integra Syringe through their predicates, nearest generation first.

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