510(k) Report

Devices descending from K040527

14 later devices reach Low Profile Luther Safety Huber through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc.2016212
+1K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.2008132
+2K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc.20176—
+2K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetC.R. Bard, Inc.20171—
+2K090809MPS Acacia Power Injectable Infusion SetMps Acacia20092—
+3K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc.20240—
+3K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.20232—
+3K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd20212—
+3K142527Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc.20141—
+4K25409525G Huber NeedleMartech Medical Products20260—
+4K243332Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.20251—
+4K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus…Intera Oncology, Inc.20210—
+4K202672Precision Delivery Infusion SetQuest Medical, Inc.202101
+5K251138Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.20250—