510(k) Report

Devices descending from K010388

3 later devices reach Sondrex P.a.L. System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151050Pacifier Activated Lullaby (PAL®)Power Medical Devices, LLC201501
+1K071866Ntrainer SystemKcbiomedix, Inc.20081—
+2K143507NFANT Feeding SolutionNfant Labs, LLC20150—