510(k) Report

Devices descending from K020641

10 later devices reach Spiritus (TM) Respiratory System #SRS 001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033759C2 Nasal MaskRespironics, Inc.20049—
+2K042130Aura Cpap Patient InterfaceAeiomed, Inc.20048—
+3K100121Model 300157 Cpap SystemAeiomed, Inc.20105—
+3K072993Reusable Headrest with Nasal SealAeiomed, Inc.20081—
+4K150365Cloud9 SystemInsleep Technologies, LLC20150—
+4K140929Z1 Cpap SystemHuman Design Medical, LLC20140—
+4K132127Transcend AutoSomnetics International, Inc.20131—
+4K121374ZI BlowerDeshum Medical20131—
+4K090804Nasal Aire II Pediatric, Model 5 Sizes, Model TBDInnomed Technologies, Inc./Respcare, Inc.20090—
+5K180388Transcend 365 miniCPAP SystemSomnetics International, Inc.20180—