510(k) Report

Devices descending from K091803

25 later devices reach Smarttrack System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133951SmarttouchNexus6, Ltd.201410—
+1K121609Asthmapolis SystemReciprocal Labs Corporation201213—
+2K180407SmartinhalerAdherium (Nz), Ltd.20184—
+2K163485SmartTouchAdherium (Nz), Ltd.20176—
+2K140638Propeller System - Model 2Reciprocal Labs Corporation201412—
+3K222247Hailie Sensor NF0110Adherium (Nz), Ltd.20231—
+3K183586CapMedicCognita Labs, LLC20190—
+3K182638Hailie SensorAdherium (Nz), Ltd.20190—
+3K182573Hailie SensorAdherium (Nz), Ltd.20190—
+3K173310SmartTouchAdherium (Nz), Ltd.20185—
+3K143671Propeller Model 2014-D SensorReciprocal Labs20154—
+3K142516Propeller SystemReciprocal Labs Corporation20158—
+3K142960Propeller System 2014-RReciprocal Labs20151—
+4K250022HeroTracker SenseVoluntis20250—
+4K223367Ochsner Connected Inhaler SensorOchsner Clinic Foundation20231—
+4K203155BreatheSuite MDI V1Breathesuite, Inc.20210—
+4K211233Hailie Sensor NF0109Adherium (Nz), Ltd.20213—
+4K181405Hailie SensorAdherium (Nz), Ltd.20180—
+4K152882Propeller SystemReciprocal Labs20163—
+4K152482Propeller Sensor Model 2014-RReciprocal Labs20160—
+5K260270FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)FindAir Sp. z o.o.20260—
+5K220622Hailie Sensor NF0106Adherium (Nz), Ltd.20220—
+5K161454Propeller Sensor Model 2015-EReciprocal Labs Corporation20162—
+6K180770Propeller Sensor for NeohalerReciprocal Labs Corporation20181—
+7K192724Propeller Sensor for SymbicortReciprocal Labs Corporation20200—