510(k) Report

Devices descending from K943597

9 later devices reach Monarch AP (TM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011811Monarch Inflation Syringe; Universal Fluid Dispensing SyringeMerit Medical Systems, Inc.2001810
+2K160107DiamondTOUCH Inflation Device and Fluid Dispensing SyringeMerit Medical Systems, Inc.201611
+2K083523Monarch Compak Inflation Syringe and Universal Fluid Dispensing SyringeMerit Medical Systems, Inc.200941
+2K050753Stryker DiscmonitorStryker Instruments20050—
+3K260035Digital Indeflator INFLANTEUAB Telemedicina20260—
+3K122321Basixconpak Analog Inflation SyringeMerit Medical Ireland, Ltd.201231
+4K130566BasixtouchMerit Medical Systems, Inc.20132—
+5K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc.20160—
+5K140943Mastro Plus Balloon in-Deflation DeviceBeijing Demax Medical Technology Co.,Ltd20150—