510(k) Report

Devices descending from K042130

8 later devices reach Aura Cpap Patient Interface through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100121Model 300157 Cpap SystemAeiomed, Inc.20105—
+1K072993Reusable Headrest with Nasal SealAeiomed, Inc.20081—
+2K150365Cloud9 SystemInsleep Technologies, LLC20150—
+2K140929Z1 Cpap SystemHuman Design Medical, LLC20140—
+2K132127Transcend AutoSomnetics International, Inc.20131—
+2K121374ZI BlowerDeshum Medical20131—
+2K090804Nasal Aire II Pediatric, Model 5 Sizes, Model TBDInnomed Technologies, Inc./Respcare, Inc.20090—
+3K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—