510(k) Report

Devices descending from K023254

53 later devices reach Speedicath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192468Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use…Hangzhou Bever Medical Devices Co., Ltd.201911
+1K180258SpeediCath StandardColoplast20181—
+1K161672SpeediCath Flex CoudeColoplast Corp.201610—
+1K121458Speedicath Compact Set (12/18 FR)Coloplast A/S20123—
+1K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…Hollister, Inc.200915—
+1K072808Speedicath CompactColoplast Corp.200712—
+1K062444HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and KitOasis Medikal Urunler Kimya Sanayi VE Tic A.S.20075—
+2K251178Ready to use Nelaton CatheterJamjoom Fullcare Corporation20260—
+2K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…Well Lead Medical Co., Ltd.20250—
+2K223756SimPro™ Now, GentleCath™ HydrophilicDentsply Sirona20230—
+2K212567PVC Hydrophilic Urethral CatheterChengdu Daxan Innovative Medical Tech. Co., Ltd.20220—
+2K203637SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812…Coloplast20222—
+2K200820SpeediCath Compact SetColoplast20200—
+2K180070SpeediCath Flex Coude ProColoplast20189—
+2K151772Actreen Mini Intermittent Urinary CathetersB.Braun Medical, Inc.20162—
+2K150935SpeediCath Compact EveColoplast A/S20150—
+2K143182Speedicath Compact MaleColoplast A/S20151—
+2K141642Vapro Intermittent CatheterHollister Incorporated201413—
+2K133615Well Lead PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.20142—
+2K122785Hydrosil; Magic; Personal CatheterRochester Medical Corp.201323
+2K121457Speedicath Compact Set (12 FR)Coloplast Corp.20124—
+2K110862Vapro Plus Intermittent CatheterHollister Incorporated201114—
+3K241028Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)Coloplast20240—
+3K220722PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd.20230—
+3K210250SpeedCath Compact MaleColoplast20220—
+3K192904SpeediCath Compact SetColoplast20200—
+3K190620SpeediCath Flex Coude ProColoplast20198—
+3K180801Actreen Hi-Lite Cath, Actreen Hi-Lite SetB.Braun Medical, Inc.20181—
+3K180824VaPro 2 Intermittent CatheterHollister Incorporated20186—
+3K163179Onli Intermittent CatheterHollister Incorporated20173—
+3K152268VAPRO PLUS POCKET Intermittent CatheterHollister Incorporated20150—
+3K150345Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc.201512
+3K143594VaPro PocketHollister Incorporated20150—
+3K142563Well Lead PVC Urethral CatheterWell Lead Medical Co., Ltd.20140—
+4K230165Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10…Coloplast20234—
+4K220667Sleeved ICHollister Incorporated20223—
+4K222059SpeediCath Flex SetColoplast20220—
+4K211436Intermittent Catheter (Not Finalized)Hollister Incorporated202201
+4K200142SpeediCath SoftColoplast20201—
+4K192577Actreen Hi-Lite Intermittent Urinary CathetersB.Braun Medical, Inc.20200—
+4K191633Infyna ChicHollister Incorporated20191—
+4K183253ValPro 2 Plus, VaPro 2 Plus PocketHollister Incorporated20181—
+4K172247Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc.201702
+5K262045Luja SoftColoplast A.S.20260—
+5K241210Luja CoudeColoplast Corp.20242—
+5K233524Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not…Hollister Incorporated20242—
+5K233101Luja Coude (20108 Male CH18 - large packaging)Coloplast Corp.20230—
+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—
+6K251116Luja CoudéColoplast Corp.20250—
+6K250270Luja SetColoplast Corp.20250—