510(k) Report

Devices descending from K911997

4 later devices reach Tenderfoot (R), Modification through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223352TenderfootAccriva Diagnostics, Inc.20230—
+1K220917gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri-Alleset, Inc.20221—
+1K172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri Medical & Electronic Technology Co., Ltd.20172—
+2K242664gentleheel® Adult Incision DeviceGri-Alleset, Inc.20240—