510(k) Report

Devices descending from K941450

23 later devices reach Inviro Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070203Invirosnap Safety Syringe, Models 120006, 120007, 120008, 100080, 130022, 130023 and…Inviro Medical Devices, Inc.20070—
+1K040036Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905Inviro Medical200410—
+1K032780Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CCInviro Medical200310—
+2K101560Medline Retractable Safety SyringeMedline Industries, Inc.20110—
+2K0924301 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock…Inviro Medical Devices, Inc.20099—
+2K092413Invirosnap 50 and 100 Unit Insulin Safety SyringesInviro Medical Devices, Inc.20090—
+2K050131Insosafe Bak'snap Retractable Insulin Safety SyringeM.K. Meditech Co., Ltd.20058—
+3K212226DR Safety Syringe, Sterile Hypodermic needle for Single useZhuhai DR Medical Instruments Co., Ltd.20210—
+3K173743Greenmedi Safety Filter SyringeSang-A Frontec Co., Ltd.20193—
+3K1620300.5ml Sol-Care Retractable Safety Syringe with Fixed NeedleSol-Millennium Medical, Inc.20160—
+3K152808U&U Insulin Syringe with/without Safety Retractable DeviceU&U Medical Technology Co, Ltd.20165—
+3K143070Disposable Safety Self-destructive Syringes, 5 MLJiangsu Yile Medical Article Co., Ltd.20150—
+3K1424363S Safety Insulin SyringeSincere Medical Device Co., Ltd.20150—
+3K121637Auto-Disable Sterile Safty Syring for Single UseSunwell Biotech Co., Ltd.20120—
+3K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc.20070—
+4K212635SofjecHwajin Medical Co., Ltd.20232—
+4K202570Insulin Syringe, Insulin Syringe with Safety RetractableJiangsu Micsafe Medical Technology Co., Ltd.20212—
+4K191639TK Insulin Syringe with/without Saftey Retractable DeviceAnhui Tiankang Medical Technology Co., Ltd.20200—
+4K193022Retractable Safety Insulin SyringeJiangsu Caina Medical Co.,Ltd20200—
+5K241856Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd.20241—
+5K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd.20221—
+6K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…Hlb Lifescience Co., Ltd.20260—
+6K230061Insulin SyringeAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.20230—