510(k) Report

Devices descending from K100528

4 later devices reach Breathe Technologies Ventilator and Accessories BT-V2S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102525Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20103—
+2K103345Breathe Technologies Ventilator and Accessories (BT-V2S)Breathe Technologies, Inc.20112—
+3K131562Breathe Niov Ventilation SystemBreathe Technologies20141—
+4K152664TAV SystemNew Aera, Inc.20160—