510(k) Report

Devices descending from K130132

9 later devices reach Babylance Heel Incision Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223900babyLance Safety Heelstick (BLM, BLN, BLP)Clinical Innovations, LLC20230—
+1K193009Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd.20197—
+2K221371Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd.20220—
+2K210745Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc.20215—
+3K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.20260—
+3K244036Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc.20250—
+3K222168Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and…Owen Mumford, Ltd.20220—
+3K220372Heel Stick Safety Lancet (HHZ-II, HHZ-III)Tianjin Huahong Technology Co., Ltd.20221—
+4K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.20260—