Atlas FDA

KOD

238 FDA 510(k) clearances · Product code

65 daysmedian time to decision
213 days90th percentile
238clearances measured

FDA profile

Official device name
Catheter, Urological
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 1,388 · 2022: 1,280 · 2023: 1,160 · 2024: 1,259 · 2025: 1,419 · 2026: 773
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Rubber Utility Catheter (K251864)C.R. Bard, Inc.2026-02-23
Wellead Ureteral Catheter (K220036)Well Lead Medical Co., Ltd.2022-12-16
allFlex Ureteral Catheters, Krait Ureteral Catheters (K220730)Allwin Medical Devices, Inc.2022-10-13
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (K211032)Urogen Pharma, Ltd.2021-11-19
Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (K181979)Teleflexmedical, Inc.2019-05-24
UroGen Ureteral Catheter (K180354)Urogen Pharma, Ltd.2018-10-30
Angled Tip Ureteral Catheter (K181144)Cook Incorporated2018-06-28
Imager II Urology Torque Catheter (K180530)Boston Scientific Corporation2018-04-10
Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (K171810)Cook Incorporated2018-03-07
Renal Access Cobra Catheter, Kumpe Access Catheter (K171600)Cook Incorporated2018-02-16
Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter (K171662)Cook Incorporated2018-02-01
GentleCath Intermittent Urinary Catheter (K172924)Convatec Limited2017-11-21
GentleCath Glide Intermittent Catheter (K161344)Convatec Limited2016-09-20
United Urologics Closed System Catheter (K160877)Robling Medical, Inc.2016-05-20
GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER (K140953)Convatec, Ltd.2014-08-01
BACKSTOP CATHETER (K110491)Pluromed, Inc.2011-03-16
BACKSTOP CATHETER (K103349)Pluromed, Inc.2011-01-07
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER (K102527)Boston Scientific Corporation2010-11-05
BACKSTOP CATHETER, MODEL 60-0000-3100 (K090270)Pluromed, Inc.2009-05-15
MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) (K080878)Medical Technologies of Georgia, Inc.2008-07-17
CURE CATHETER CLOSED SYSTEM (K080881)Cure Medical, LLC2008-06-11
DOVER ROB-NEL CATHETER (K040897)Tyco Healthcare2004-07-20
DOVER RED RUBBER ROBINSON CATHETER (K041243)Tyco Healthcare2004-07-07
BARD TIGERTAIL URETERAL CATHETER (K033719)C.R. Bard, Inc.2004-02-04
CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT (K032710)Apogee Medical, Inc.2004-01-09
INTERMITTENT URETHRAL CATHETERS (K033023)Rusch Intl.2003-12-23
URETERAL ACCESS SHEATH SET (UASS) (K022135)Boston Scientific Corp2002-09-13
INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT (K013483)Hollister, Inc.2002-01-14
INCARE INTERMITTENT CATHETER (K013345)Hollister, Inc.2002-01-07
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 (K011965)Boston Scientific Corp2001-07-13
ENDOCARE PERCUTANEOUS ACCESS SET (K010339)Endocare, Inc.2001-03-07
ENDOCARE PERCUTANEOUS ACCESS SET (K002396)Endocare, Inc.2000-10-13
ISLAND BIOSURGICAL BNS KIT #3 (K001583)Island Biosurgical, LLC2000-07-13
HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC) (K000723)Rochester Medical Corp.2000-05-19
FLOCATH (K000070)Rusch Intl.2000-02-18
IMAGER TORQUE CATHETER (K965229)Boston Scientific Corp1997-03-04
URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT (K951260)Biosearch Medical Products, Inc.1995-09-27
NOPROFILE OLBERT CATHETER SYSTEM (K945061)Meadox Surgimed, Inc.1995-03-09
BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY (K922527)C.R. Bard, Inc.1994-04-14
4SURE URO-LINK UROLOGICAL PROCEDURE TRAYS (K933109)Boston Pacific Medical, Inc.1994-03-28
FLOWMATE HAND PUMP (K915459)Psi Medical Products, Inc.1994-02-15
PERCUTANEOUS DRAINAGE LOOP CATHETER SET (K931195)Cook Urological, Inc.1993-12-22
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR (K933400)Kendall Healthcare Products Co. Div.Of Tyco Health1993-11-15
ONIK-COHEN ACCESS SET (K930608)Cook Urological, Inc.1993-07-09
FOLEY INSERTION TRAY (K923906)Kit Pak, Inc.1993-06-22
KIT PAK'S FLUSHING KIT (K922051)Kit Pak, Inc.1993-06-17
BARD LATEX URINARY CATHETERS (K922431)C.R. Bard, Inc.1993-03-25
RADIFOCUS GUIDE WIRE M (K923607)Terumo Medical Corp.1992-10-02
KENDALL MOD. PEDIATRIC ULTRAMER POLYURETHANE CATH. (K921054)Kendall Healthcare Products Co. Div.Of Tyco Health1992-09-23
IRRIGATION TUBING SET (K921415)Psi Medical Products, Inc.1992-09-04
INSTRUMENT IRRIGATION PUMP (K921253)Psi Medical Products, Inc.1992-08-06
HEART PACK III (K914933)Westmark Hospital Supplies1992-01-31
NAUDE URETHRAL STENT (K912851)Cook Urological, Inc.1992-01-30
KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER (K911242)Kendall Healthcare Products Co. Div.Of Tyco Health1991-04-25
NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH (K900509)Medical Latex Corp.1990-12-14
PHARMASEAL DISPOSABLE ABDOMINAL TROCAR (K904734)Baxter Healthcare Corp1990-11-21
NELATON-, FEMALE - OR TIEMANN CATHETER (K896729)Unoplast A/S1990-11-05
LOFRIC(R), LOFRIC(R) CATH-KIT (K896750)Astra Meditec AB1990-08-06
SELFCATH (K901738)Vitaid, Ltd.1990-06-27
BARD CONFORMACATH FOLEY CATHETER (K900229)C.R. Bard, Inc.1990-04-17
BJ STAR ALL SILICONE FOLEY BALLOON CATHETER (K900022)B.J. Star, Inc.1990-03-15
4 SURE EXTERNAL MALE CATHETER (K896726)The Boston & Pacific Co., Inc.1990-02-26
4 SURE UROLOGICAL CATHETER (K896725)The Boston & Pacific Co., Inc.1990-02-16
DISPOSABLE URODYNAMIC CATHETER SET (K896784)Life-Tech Intl., Inc.1990-02-16
ALL SILICONE FOLEY CATHETER (K896053)Rochester Medical Corp.1990-02-12
CONVEEN INTERMITTENT CATHETERS (K895548)Coloplast A/S1990-02-09
URETERAL ACCESS SET (K896385)Applied Urology, Inc.1990-01-22
CYSTOSCOPY/IRRIGATION SET (K896211)Westmark, Sterile Packing Systems, Inc. (Sps)1990-01-18
Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET (K896213)Westmark, Sterile Packing Systems, Inc. (Sps)1990-01-18
CYSTO PUMP DRAINAGE BAG (K896208)Westmark, Sterile Packing Systems, Inc. (Sps)1990-01-18
MODIFIED URINARY CATHETER INTRODUCER (UCI) (K890400)Go Medical Industries Pty. , Ltd.1989-09-12
MODIFIED PRISTINE CULTURE CATHETER (K893390)Hml Medical, Inc.1989-09-07
KENDALL CURITY IRRIGATION SYRINGE (K892436)The Kendal Co.1989-07-14
CATHETERS, MALE, FEMALE (K892691)Zinnanti Surgical Instruments, Inc.1989-06-23
16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR (K885202)Coeur Laboratories, Inc.1989-01-31
ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH (K883763)Acme-Monaco Corp.1988-11-18
ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM (K881981)Ryder Intl. Corp.1988-08-02
CATHETER STRAP (K881781)Baxter Healthcare Corp1988-08-02
SYRINGE PREFILLED WITH WATER (K881363)I M, Inc.1988-06-23
UROLOGICAL CATHETER (K881646)Coeur Laboratories, Inc.1988-06-16
COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING (K880100)Cook Urological, Inc.1988-03-15
LAKE CATHETER CARE KITS (MODIFICATION) (K875383)Lake Medical Products, Inc.1988-03-09
VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER (K874112)Van-Tec, Inc.1988-02-11
MMG CATHETER PLUG W/DRAINAGE TUBE COVER (K874682)Medical Marketing Group1988-01-27
MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR (K874525)Mon-A-Therm, Inc.1988-01-06
ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET (K874293)Ackrad Laboratories1987-12-29
ACKRAD RETROGRADE URETHROGRAPHY SET (K874312)Ackrad Laboratories1987-12-29
FOLEY CATHETER TEMPERATURE SENSOR (K873448)Respiratory Support Products, Inc.1987-12-07
PHARMASEAL RUBBER URETHRAL CATHETER (K874517)American Pharmaseal Div. Ahsc1987-12-03
IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE) (K873287)Todd Medical, Inc.1987-11-13
LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET (K873435)Level 1 Technologies, Inc.1987-10-05
LAKE CATHETER CARE KIT (K872750)Lake Medical Products, Inc.1987-09-03
ANTIMICROBIAL FOLEY CATHETER (K871429)American Pharmaseal Div. Ahsc1987-08-10
JUDD URETHAL CATHETER CONTAINER (K864592)Phil Judd, Inc.1987-06-24
FOLEY CATHETER (K870165)Acorn Medical Products1987-04-17
KADIR HI-TORQUE GUIDE WIRE (K871297)Argon Medical Corp.1987-04-10
PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE (K870977)American Pharmaseal Div. Ahsc1987-04-01
VAN-TEC PUMPING SYSTEM (K870557)Van-Tec, Inc.1987-03-30
VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER (K870694)Van-Tec, Inc.1987-03-10
AKRO-SIL PLUS (K864736)Akron Catheter, Inc.1986-12-24
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