510(k) Report

Devices descending from K092430

9 later devices reach 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212226DR Safety Syringe, Sterile Hypodermic needle for Single useZhuhai DR Medical Instruments Co., Ltd.20210—
+1K173743Greenmedi Safety Filter SyringeSang-A Frontec Co., Ltd.20193—
+1K1620300.5ml Sol-Care Retractable Safety Syringe with Fixed NeedleSol-Millennium Medical, Inc.20160—
+1K143070Disposable Safety Self-destructive Syringes, 5 MLJiangsu Yile Medical Article Co., Ltd.20150—
+1K121637Auto-Disable Sterile Safty Syring for Single UseSunwell Biotech Co., Ltd.20120—
+1K101560Medline Retractable Safety SyringeMedline Industries, Inc.20110—
+2K212635SofjecHwajin Medical Co., Ltd.20232—
+3K241856Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd.20241—
+4K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd.20260—