Atlas FDA

EZD

86 FDA 510(k) clearances · Product code

140 daysmedian time to decision
300 days90th percentile
86clearances measured

FDA profile

Official device name
Catheter, Straight
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 994 · 2022: 487 · 2023: 553 · 2024: 116 · 2025: 291 · 2026: 146
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
Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). (K260737)Convatec2026-08-05
LoFric Origo Pro Coudé (K261658)Wellspect AB2026-07-17
Luja Soft (K262045)Coloplast A.S.2026-07-07
Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) (K260394)Hangzhou Jimushi Meditech Co., Ltd.2026-06-24
Coude Sleeved IC; Coude Plus Sleeved IC (K253295)Hollister Incorporated2026-05-18
LoFric Elle Pro (K260999)Wellspect AB2026-04-24
GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women (K252943)Convatec Limited2026-04-01
Liv Pre-lubricated Intermittent Catheter (K260502)HR Healthcare2026-03-12
EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits (K251274)HR Healthcare2026-01-29
Ready to use Nelaton Catheter (K251178)Jamjoom Fullcare Corporation2026-01-02
Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) (K251468)Hollister Incorporated2025-10-03
LoFric Origo (K250659)Wellspect AB2025-09-26
Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) (K250699)Convatec2025-07-01
Luja Coudé (K251116)Coloplast Corp.2025-06-27
Disposable Intermittent Catheter (TPU Catheter) (K243175)Chengdu Daxan Innovative Medical Tech. Co., Ltd.2025-06-26
Luja Set (K250270)Coloplast Corp.2025-04-17
SureCath Set (K242049)Coloplast Corp.2024-11-26
Luja Coude (K241210)Coloplast Corp.2024-11-21
Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) (K241028)Coloplast2024-07-26
Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) (K233524)Hollister Incorporated2024-05-03
GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) (K232665)Convatec2024-01-25
Cure Catheter Closed System; Cure Dextra Closed System (K230400)Convatec, Inc.2023-11-08
Luja Coude (20108 Male CH18 - large packaging) (K233101)Coloplast Corp.2023-10-26
Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) (K230165)Coloplast2023-08-25
PVC Hydrophilic Urethral Catheter (K220722)Well Lead Medical Co., Ltd.2023-05-22
SimPro™ Now, GentleCath™ Hydrophilic (K223756)Dentsply Sirona2023-05-04
Intermittent nelaton catheter for single use (K222677)Hangzhou Jimushi Meditech Co., Ltd.2023-04-05
Sleeved IC (K220667)Hollister Incorporated2022-12-08
PVC Hydrophilic Urethral Catheter (K212567)Chengdu Daxan Innovative Medical Tech. Co., Ltd.2022-12-07
Self-Cath and Self-Cath Plus (K221401)Coloplast2022-12-02
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus (K221593)Convatec, Inc.2022-11-17
SpeediCath Flex Set (K222059)Coloplast2022-09-21
Female IC (Not Finalized) (K213575)Hollister Incorporated2022-09-13
BONREE Nelaton Catheter (K212430)Bonree Medical Co., Ltd.2022-04-29
SpeedCath Compact Male (K210250)Coloplast2022-04-26
SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) (K203637)Coloplast2022-03-08
LoFric Elle (K211212)Dentsply Sirona2022-02-17
Wiygul Catheter (K202566)Big Blue Biotech, Inc.2020-09-30
AMSure Hydrophilic Intermittent Catheter (K181445)Amsino International, Inc.2018-10-01
COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter (K180738)Compactcath, Inc.2018-06-14
Medline Catheter Specimen Collector (K172541)Medline Industries, Inc.2018-02-22
Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) (K170233)Zhanjiang Star Enterprise Co., Ltd.2017-10-13
Magic3 Go Intermittent Urinary Catheter (K172247)C.R. Bard, Inc.2017-09-20
PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C (K161445)Adapta Medical, Inc.2016-08-16
CompactCath Intermittent Urinary Catheter (K160858)Compactcath, Inc.2016-04-26
FULL CARE Disposable PVC Nelaton Catheter (K151745)Shaoxing Fuqing Health Products Co., Ltd.2016-03-03
Magic3 Go Intermittent Urinary Catheter (K150345)C.R. Bard, Inc.2015-05-11
Bard RiteCath Intermittent Urinary Catheter (K142575)C.R. Bard, Inc.2014-10-31
Well Lead PVC Urethral Catheter (K142563)Well Lead Medical Co., Ltd.2014-10-28
COMPACTCATH INTERMITTENT URINARY CATHETER (K140945)Compactcath, Inc.2014-08-22
BARD RITECATH INTERMITTENT CATHETER (K133470)C.R. Bard, Inc.2014-04-04
WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER (K133615)Well Lead Medical Co., Ltd.2014-02-24
CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED (K132500)Cure Medical, LLC2013-12-23
CLASSIC INTERMITTENT CATHETER (K132619)Flexicare Medical, Ltd.2013-10-11
HYDROSIL; MAGIC; PERSONAL CATHETER (K122785)Rochester Medical Corp.2013-05-14
LOFRIC SENSE (K123751)Wellspect Healthcare2013-02-28
LOFRIC PRIMO, LOFRIC HYDRO-KIT (K122078)Astra Tech, Inc.2012-10-31
LOFRIC SINGLE USE URINARY CATHETER (K113424)Astra Tech AB2012-04-17
COMFORTGLIDE INTERMITENT CATHETER (K112137)C.R. Bard, Inc.2011-08-26
CURE CATHETER (K110653)Cure Medical, LLC2011-08-01
DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC (K103086)Dynarex Corporation2011-06-07
COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH (K103043)Adapta Medical, Inc.2011-01-07
MEDLINE PVC URETHRAL CATHETER (K100302)Medline Industries, Inc.2010-07-02
SELF CATH CATHETER (K100878)Coloplast Manufacturing Us, LLC2010-05-26
AMSURE PVC INTERMITTENT CATHETER (K091306)Amsino International, Inc.2009-08-21
FOOTPRINT URINARY DRAINAGE CATHETER (K090576)Footprint Medical2009-08-12
GRADUATED ADAPTER WITH CLAVE (K080007)Icu Medical, Inc.2008-05-13
NEOMED URINARY CATHETER (K072997)Neomed, Inc.2007-12-19
CURE CATHETER (K072539)Cure Medical, LLC2007-09-13
EXPRESSWAY INTERMITTENT CATHETER (K061766)Percutaneous Systems, Incorporated2007-03-09
HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT (K062444)Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.2007-02-22
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (K052440)Mentor Corporation2005-10-11
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER (K050008)Mentor Corp.2005-06-03
BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER (K041464)Busse Hospital Disposables2004-11-05
SLIP UROLOGY CATHETER (K040519)Percutaneous Systems, Inc.2004-05-20
VITALCARE URETHRAL CATHETER RED RUBBER (K023872)Vitalcare, Inc.2003-04-10
AMERICAN CATHETER, MODEL W3 (K030538)Catheter, LLC2003-03-10
MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006 (K993226)Memcath Technologies, LLC1999-12-10
KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER (K973546)Kendall Healthcare Products Co. Div.Of Tyco Health1997-11-07
CONVEEN EASICATH SET (K973070)Coloplast Corp.1997-11-06
ORION RED URETHRAL CATHETER (K944383)Regulatory & Marketing Services, Inc.1994-12-06
CATCO UROLOGICAL CATHETER (K944782)Catco Medical, Inc.1994-10-13
GOOSEN SELF-LUBRICATING CATHETER (K923848)Goosen Enterprises, Inc.1994-02-18
4-SURE NELATON CATHETER (K931048)Boston Pacific Medical, Inc.1994-02-14
4-SURE FEMALE CATHETER (K931047)Boston Pacific Medical, Inc.1994-02-14
TAYLOR CATHETER HOLDER (K780411)Taylor Catheter Holder Mfg.1978-04-13

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Every clearance here is in the API, with alerts when new ones post.