510(k) Report

Devices descending from K110127

13 later devices reach Prelude Iii Tongue Suspension System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+1K111179Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue…Siesta Medical, Inc.20116—
+2K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+2K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+2K121440Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc.20124—
+2K121814Encore Tongue Suspension SystemSiesta Medical, Inc.20120—
+2K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+3K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+3K133680Encore SystemSiesta Medical, Inc.20143—
+4K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+4K183310Encore SystemSiesta Medical, Inc.20192—
+5K201238Encore SystemSiesta Medical, Inc.20201—
+6K213159Encore SystemSiesta Medical, Inc.20210—