510(k) Report

Devices descending from K062438

11 later devices reach Bakri Postpartum Balloon, Model J-Sos-100500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170622Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentCook Incorporated20176—
+1K101535BT-CathUtah Medical Products, Inc.20110—
+1K091958Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC20102—
+2K230849Ellavi UbtSinapi Biomedical (Pty), Ltd.20230—
+2K223098Bakri Essential Postpartum BalloonCook Incorporated20220—
+2K201199Jada SystemAlydia Health20202—
+2K191264Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)Ujenzi Charitable Trust20190—
+2K150573ebb Complete Tamponade SystemClinical Innovations, LLC201511
+3K212757Jada SystemAlydia Health20211—
+3K153591ebb Complete Tamponade SystemClinical Innovations, LLC20160—
+4K253642Jada System (Jada-2002)Organon, LLC20260—