510(k) Report

Devices descending from K101417

10 later devices reach Babylance Heel Incision Device , Models BLP50, BLP200, BLN50, BLN200 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130132Babylance Heel Incision DeviceMedipurpose Pte., Ltd.20139—
+2K223900babyLance Safety Heelstick (BLM, BLN, BLP)Clinical Innovations, LLC20230—
+2K193009Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd.20197—
+3K221371Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd.20220—
+3K210745Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc.20215—
+4K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.20260—
+4K244036Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc.20250—
+4K222168Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and…Owen Mumford, Ltd.20220—
+4K220372Heel Stick Safety Lancet (HHZ-II, HHZ-III)Tianjin Huahong Technology Co., Ltd.20221—
+5K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.20260—