510(k) Report

Devices descending from K192551

14 later devices reach 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213010FEELject LDV (Low dead volume) syringeFeeltech Co., Ltd.20232—
+1K221308Disposable Syringe with permanently attached needle, Safety Syringe with permanently…Jiangxi Maidikang Medical Devices Co., Ltd.20220—
+1K213013Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV SyringeJeil Tech Co., Ltd.20220—
+1K213158Syringe with permanently attached needleBerpu Medical Technology Co., Ltd.20220—
+1K220204Disposabel Syringe with permanently attached needle, Safety Syringe with permanently…Anhui Tiankang Medical Technology Co., Ltd.20220—
+1K210443PLPT LDV (Low Dead Volume) Sterile SyringePoonglim Pharmatech, Inc.20216—
+2K250127TSK SyringeTsk Laboratory, Japan20250—
+2K250138Small Volume 0.2mL SyringeProsum Medical Limited20250—
+2K231856TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd20241—
+2K231165Shina Syringe; Shina Safety SyringeShina Med Corporation20230—
+2K221860PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe, PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc.20231—
+2K220083LDV ((Low Dead Volume )SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20220—
+3K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead…CMT Health PTE., Ltd.20260—
+3K241190PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe; PLPT LDV (Low Dead Volume) LL…Poonglim Pharmatech, Inc.20240—