510(k) Report

Devices descending from K043132

10 later devices reach Universal Xacttrace through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173793XactTrace Single Use Respiratory Effort Belt SystemEmbla Systems20191—
+1K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc.20097—
+2K242424Bluebird Single-Use Respiratory Effort BeltCadwell Industries, Inc.20240—
+2K151940Thora-3Di, Model T-01Pneumacare Limited20163—
+2K103631Sleepminder Breathing Frequency IndicatorBiancamed Limited20111—
+2K100773Kai Spot Model KMS 200Kai Medical, Inc.20100—
+3K242001Philips VSC-MEDlibPhilips Medical Systems Nederland B.V.20252—
+3K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.20200—
+4K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.20251—
+5K253650Anura Mobile Core SDK (M1)Nuralogix Corporation20260—