510(k) Report

Devices descending from K181666

3 later devices reach Smart One through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200832Safey Peak Flow MeterSafey Medical Devices Pvt, Ltd.20200—
+1K193311AlunaKnox Medical Diagnostics, Inc.20201—
+2K232588Aluna 2Knox Medical Diagnostics20240—