510(k) Report

Devices descending from K103150

6 later devices reach Kimberly-Clark Child/Pediatric Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113340Kimberly-Clark Child's FacemaskKimberly-Clark20125—
+2K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc.20220—
+2K160100Prestige Ameritech Pediatric/Child’s Face maskPrestige Ameritech20164—
+3K221753Kangbeier Child Surgical MaskXinxiang Kangbeier Medical Technology Co., Ltd.20230—
+3K210321Dukal Corporation Level 1 Pediatric Face MaskDukal Corporation20221—
+3K190308Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom…Amd Medicom, Inc.20190—