510(k) Report

Devices descending from K043241

9 later devices reach Lofric Hydro-Kit II Single Use Urinary Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122078Lofric Primo, Lofric Hydro-KitAstra Tech, Inc.201223
+1K062444HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and KitOasis Medikal Urunler Kimya Sanayi VE Tic A.S.20075—
+2K250659LoFric OrigoWellspect AB20251—
+2K223756SimPro™ Now, GentleCath™ HydrophilicDentsply Sirona20230—
+2K212567PVC Hydrophilic Urethral CatheterChengdu Daxan Innovative Medical Tech. Co., Ltd.20220—
+2K133615Well Lead PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.20142—
+3K261658LoFric Origo Pro CoudéWellspect AB20260—
+3K220722PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.20230—
+3K142563Well Lead PVC Urethral CatheterWell Lead Medical Co., Ltd.20140—