510(k) Report

Devices descending from K904026

3 later devices reach Inflat-O-Ball through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993308Mentor Evacare Vaginal PessariesMentor Corp.19992—
+2K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support…Cooper Surgical20260—
+2K250438CooperSurgical Milex® PessariesCooperSurgical, Inc.20250—