Atlas FDA

GBM

71 FDA 510(k) clearances · Product code

90 daysmedian time to decision
261 days90th percentile
71clearances measured

FDA profile

Official device name
Catheter, Urethral
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 102 · 2022: 283 · 2023: 202 · 2024: 468 · 2025: 320 · 2026: 339
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact (K241734)Well Lead Medical Co., Ltd.2025-03-05
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter (K213283)Convatec Limited2022-06-22
Intermittent Catheter (Not Finalized) (K211436)Hollister Incorporated2022-01-27
SpeediCath Compact Set (K200820)Coloplast2020-11-13
SpeediCath Compact Set (K192904)Coloplast2020-11-02
SpeediCath Soft (K200142)Coloplast2020-07-30
Jimushi Sterile Urethral Catheter for single use (K200134)Hangzhou Jimushi Meditech Co., Ltd.2020-06-01
LotusCatheter (Lotus No Balloon Catheter) (K191512)Hakki Medical Technologies, Inc.2020-05-21
Actreen Hi-Lite Intermittent Urinary Catheters (K192577)B.Braun Medical, Inc.2020-05-07
VaPro Plus Pocket, VaPro Plus (K193148)Hollister Incorporated2019-12-13
Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter (K192468)Hangzhou Bever Medical Devices Co., Ltd.2019-11-27
Infyna Chic (K191633)Hollister Incorporated2019-07-19
SpeediCath Flex Coude Pro (K190620)Coloplast2019-07-10
Medline Poly-Cath Red Polymer Urethral Catheter (K183335)Medline Industries, Inc.2019-06-12
Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter (K183461)Teleflexmedical, Inc.2019-05-08
SimplCath (K182511)F&S Medical Solutions, LLC2019-03-20
ValPro 2 Plus, VaPro 2 Plus Pocket (K183253)Hollister Incorporated2018-12-18
Actreen Hi-Lite Cath, Actreen Hi-Lite Set (K180801)B.Braun Medical, Inc.2018-11-05
SpeediCath Standard (K180258)Coloplast2018-10-25
GentleCath Glide Intermittent Urinary Catheter (K181206)Convatec Limited2018-08-16
VaPro 2 Intermittent Catheter (K180824)Hollister Incorporated2018-06-22
SpeediCath Flex Coude Pro (K180070)Coloplast2018-02-02
Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent (K172278)Cook Incorporated2017-11-22
Onli Intermittent Catheter (K163179)Hollister Incorporated2017-01-26
SpeediCath Flex Coude (K161672)Coloplast Corp.2016-09-29
United Urologics Intermittent Catheter (K160795)Robling Medical2016-06-16
Actreen Mini Intermittent Urinary Catheters (K151772)B.Braun Medical, Inc.2016-02-09
VAPRO PLUS POCKET Intermittent Catheter (K152268)Hollister Incorporated2015-09-09
SpeediCath Compact Eve (K150935)Coloplast A/S2015-07-02
ThinkMed Intermittent Catheter with/without Hydrophilic Coating (K142767)Thinkmed Medical Technology Co., Ltd.2015-02-03
Speedicath Compact Male (K143182)Coloplast A/S2015-01-20
VaPro Pocket (K143594)Hollister Incorporated2015-01-09
VAPRO INTERMITTENT CATHETER (K141642)Hollister Incorporated2014-08-22
SPEEDICATH COMPACT SET (12 FR) (K121457)Coloplast Corp.2012-10-02
SPEEDICATH COMPACT SET (12/18 FR) (K121458)Coloplast A/S2012-10-01
BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, (K111405)Hangzhou Bever Medical Devices Co., Ltd.2012-02-13
VAPRO PLUS INTERMITTENT CATHETER (K110862)Hollister Incorporated2011-04-26
HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH (K101900)Hakki Medical Technologies, Inc.2011-02-07
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184, (K090960)Hollister, Inc.2009-08-20
SPEEDICATH COMPACT (K072808)Coloplast Corp.2007-11-09
GUARDIANCATHETER-URINARY DRAINAGE CATHETER (K063795)Marian Medical, Inc.2007-03-05
PEDIATRIC URINARY CATHETER (K060268)Clay Kennard2006-02-24
ASTRA TECH AB LOFRIC PRIMO SINGLE USE URINARY CATHETER (K050874)Astra Tech, Inc.2005-05-05
LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER (K043241)Astra Tech, Inc.2004-12-23
URINARY CATHETERS (K031409)Promedic, Inc.2003-06-17
VITALCARE URETHRAL CATHETER (K021938)Vitalcare, Inc.2003-04-22
SPEEDICATH (K023254)Coloplast Corp.2003-01-27
RUSCH FLONEIL; FLOCATH INTROGEL (K020714)Rusch Intl.2002-07-01
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER (K012374)Astra Tech, Inc.2001-08-23
UROLOGICAL CATHETER (K011552)Apogee Medical, Inc.2001-07-18
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER (K993651)Sc Hennig Enterprises Europe Srl1999-12-23
UROLOGICAL CATHETER (K992137)Apogee, Inc.1999-09-03
READYCATH CATHETER (K973120)Medical Technologies of Georgia1998-02-25
PERSONAL CATHETER (K970704)Rochester Medical Corp.1997-03-13
DILATION CATHETER, BALLOON (K965067)Boston Scientific Corp1997-01-28
ASTA-CATH (K961361)A+ Products1996-10-31
ADI CATHETER WITH VALVE (K952924)Asia Dynamics, Inc.1995-08-18
ALL SILICONE INTERMITTENT CATHETER (K943851)Rochester Medical Corp.1995-01-31
URI-CATH CATHETER (K941672)Gesco Intl., Inc.1994-05-16
WALTHER CATHETERS, MALE, FEMALE (K926369)Thomasville Medical Assoc.1993-05-21
ENTRAC(TM) URETHRAL MEASURING CATHETER (K914905)American Medical Systems, Inc.1992-03-20
AUTOCATH(TM) SET (K910876)Cook Urological, Inc.1991-05-28
ALBERT MORTON UROLOGICAL CATHETER (K901441)Transinternational Marketing Group1990-06-22
ASI HEMOSTASIS CATHETER (K901336)Advanced Surgical Intervention, Inc.1990-06-20
KENDALL CURITY URETHRAL CATHETERS (K892442)The Kendal Co.1989-06-23
KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH (K881667)The Kendal Co.1988-08-12
MMG URO-SELF CATHETER (K871999)Medical Marketing Group1987-08-25
OPEN ENDED URETERAL CATHETER (K830840)Van-Tec, Inc.1983-04-06
TRAY, UNIVERSAL FOLY WO/DRAINAGE BAG (K760253)C.R. Bard, Inc.1976-08-23
TRAY, FOLEY CATHETER (K760254)C.R. Bard, Inc.1976-08-23
CATHETER, SILICONE FOLEY (BARDEX) (K760093)C.R. Bard, Inc.1976-08-23

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