510(k) Report

Devices descending from K160100

4 later devices reach Prestige Ameritech Pediatric/Child’s Face mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221753Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd.20230—
+1K210321Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation20221—
+1K190308Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom…Amd Medicom, Inc.20190—
+2K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc.20220—