510(k) Report

Devices descending from K050874

33 later devices reach Astra Tech AB Lofric Primo Single Use Urinary Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181206GentleCath Glide Intermittent Urinary CatheterConvatec Limited20183—
+1K161344GentleCath Glide Intermittent CatheterConvatec Limited20164—
+1K122078Lofric Primo, Lofric Hydro-KitAstra Tech, Inc.201223
+1K111405Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip…Hangzhou Bever Medical Devices Co., Ltd.20122—
+1K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…Hollister, Inc.200915—
+1K062444HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and KitOasis Medikal Urunler Kimya Sanayi VE Tic A.S.20075—
+2K252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenConvatec Limited20260—
+2K250659LoFric OrigoWellspect AB20251—
+2K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for…Convatec20241—
+2K223756SimPro™ Now, GentleCath™ HydrophilicDentsply Sirona20230—
+2K212567PVC Hydrophilic Urethral CatheterChengdu Daxan Innovative Medical Tech. Co., Ltd.20220—
+2K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited20221—
+2K161445PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro CAdapta Medical, Inc.20160—
+2K142767ThinkMed Intermittent Catheter with/without Hydrophilic CoatingThinkmed Medical Technology Co., Ltd.20150—
+2K141642Vapro Intermittent CatheterHollister Incorporated201413—
+2K133615Well Lead PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.20142—
+2K110862Vapro Plus Intermittent CatheterHollister Incorporated201114—
+3K261658LoFric Origo Pro CoudéWellspect AB20260—
+3K220722PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.20230—
+3K180824VaPro 2 Intermittent CatheterHollister Incorporated20186—
+3K163179Onli Intermittent CatheterHollister Incorporated20173—
+3K152268VAPRO PLUS POCKET Intermittent CatheterHollister Incorporated20150—
+3K143594VaPro PocketHollister Incorporated20150—
+3K142563Well Lead PVC Urethral CatheterWell Lead Medical Co., Ltd.20140—
+4K220667Sleeved ICHollister Incorporated20223—
+4K211436Intermittent Catheter (Not Finalized)Hollister Incorporated202201
+4K191633Infyna ChicHollister Incorporated20191—
+4K183253ValPro 2 Plus, VaPro 2 Plus PocketHollister Incorporated20181—
+5K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not…Hollister Incorporated20242—
+5K213575Female IC (Not Finalized)Hollister Incorporated20220—
+5K193148VaPro Plus Pocket, VaPro PlusHollister Incorporated20190—
+6K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated20260—
+6K251468Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not…Hollister Incorporated20250—