510(k) Report

Devices descending from K953293

24 later devices reach PM Positioner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972023Sleep-in Bone Screw SystemInfluence, Inc.199723—
+2K101060Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc.201015—
+2K040417Pillar Palatal Implant SystemRestore Medical, Inc.20040—
+2K981677Repose Bone Screw SystemInfluence, Inc.1999162
+3K122391Medtronic Xomed, Inc.Medtronic Xomed, Inc.20134—
+3K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+3K103179Prelude II Tounge Suspension SystemSiesta Medical, Inc.201014—
+3K011723Anti-Snoring Device or AsdPi Medical20024—
+4K183310Encore SystemSiesta Medical, Inc.20192—
+4K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+4K133680Encore SystemSiesta Medical, Inc.20143—
+4K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+4K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K110623Pillar Palatal Implant SystemMedtronic Xomed, Inc.20122—
+4K110127Prelude Iii Tongue Suspension SystemSiesta Medical, Inc.201113—
+5K201238Encore SystemSiesta Medical, Inc.20201—
+5K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K181107Elevo® Kit Snoring Intervention DeviceZelegent, Inc.20181—
+5K111179Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue…Siesta Medical, Inc.20116—
+6K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+6K213475Elevo Snoring Intervention SetZelegent, Inc.20220—
+6K213159Encore SystemSiesta Medical, Inc.20210—
+6K121440Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc.20124—
+6K121814Encore Tongue Suspension SystemSiesta Medical, Inc.20120—