510(k) Report

Devices descending from K981853

40 later devices reach Bone Injection Gun (B.I.G.) Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142086Nio -Intraosseous DeviceWaismed, Ltd.201431
+1K132583EZ-IO Intraosseous Infusion SystemVidacare Corporation20140—
+1K062940Bone Injection Gun (B.I.G.)Waismed, Ltd.20065—
+1K032885Vidaport Intraosseous Infusion SystemVidacare Corporation200438—
+1K022415Bone Injection Gun (B.I.G.) for Pediatrics, Model 1STWaismed, Ltd.200217—
+2K211968NIO+ AdultWaismed, Ltd.202101
+2K160805NIO-PWaismed, Ltd.201611
+2K091140EZ-Mio Distal Tibia, EZ-IO Distal Tibia, Vidaport Intraosseous Infusion System, EZ-IOVidacare Corporation200921
+2K070759Powered EZ-IO Pediatric Bone Marrow Aspiration SystemVidacare Corporation20073—
+2K062956EZ-Mio, EZ-IO Distal TibiaVidacare Corporation20063—
+2K062833Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation200614—
+2K052408EZ-IOVidacare Corporation200591
+2K052195EZ-Mio Manual DriverVidacare Corporation200513—
+2K051992Powered PD-IO Intraosseous Infusion SystemVidacare Corporation20053—
+2K043490PD-IO Disposable Intraosseous Infusion NeedleVidacare Corporation200516—
+3K191258Intraosseous infusion deviceEinstein Works, LLC20190—
+3K190538NIO-IWaismed, Ltd.20191—
+3K142377The OnControl Bone Marrow Biopsy System by VidacareVidacare, LLC201424
+3K101026Powered PD-IO Infusion System, EZ-IO Humeral Head, Powered PH-IOVidacare Corporation20101—
+3K080865FAST1 Intraosseous Infusion SystemPyng Medical Corp.20083—
+3K072045Oncontrol Bone Marrow Biopsy SystemVidacare Corporation20077—
+3K071732MarrowminerStemcor Systems, Inc.20074—
+3K063567EZ-Mio SternalVidacare Corporation20071—
+3K063142Manual PD-IO; Powered PD-IOVidacare Corporation20062—
+3K062422Humeral Head, Manual DriverVidacare Corporation20060—
+4K230015OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power…Laurane Medical Sas20230—
+4K213896BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular20220—
+4K211395NIO-IEinstein Works, LLC20210—
+4K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous DeviceTeleflex Medical20180—
+4K152474Avitus Bone HarvesterAvitus Orthopaedics, Inc.201531
+4K141910Intraosseous Cannula System Bio-MAC¿ and Bio-COREBiologic Therapies, Inc.201502
+4K130487Fastresponder Sternal Intraosseous DevicePyng Medical Corp.20131—
+4K120661The T.a.L.O.N. Intraossous Infusion System by VidacreVidacare Corporation201201
+4K100124Fastx Sternal Intraosseous DevicePyng Medical Corp.201021
+4K081713Vertebral Access System by VidacareVidacare Corporation20084—
+5K170539Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone…Avitus Orthopaedics, Inc.201721
+5K112468The Oncontrol Bone Access System by VidacareRegulatory Specialists, Inc.20113—
+6K210631Avitus (r) Bone HarvesterAvitus Orthopaedics, Inc.20211—
+6K113872The Oncontrol Bone Access and Bone Biopsy System by VidacareVidacare Corporation201222
+7K243407Forcyte Autograft Harvest KitForcyte Medical, LLC20250—