Atlas FDA

FCM

60 FDA 510(k) clearances · Product code

73 daysmedian time to decision
129 days90th percentile
60clearances measured

FDA profile

Official device name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 85 · 2022: 59 · 2023: 48 · 2024: 54 · 2025: 37 · 2026: 45
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
BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit (K254076)C.R. Bard, Inc.2026-05-29
Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C (K250891)Convatec Limited2025-06-06
Self-Cath Closed System (K223821)Coloplast2023-08-02
AMSELF CLOSED CATHETERIZATION SYSTEM (K082831)Amsino International, Inc.2008-10-23
SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM (K070939)Coloplast Manufacturing Us, LLC2007-06-01
GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (K070048)Marian Medical, Inc.2007-03-15
AMSURE URETHRAL CATHETERIZATION TRAY (K030712)Amsino International, Inc.2003-05-23
AMSURE FOLEY INSERTION TRAY (K030664)Amsino International, Inc.2003-05-23
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (K011055)Go Medical Industries Pty. , Ltd.2001-06-06
RUSCH MMG/O'NEIL CATHETER (K010420)Rusch, Inc.2001-05-09
MENTOR SELF-CATH CLOSED SYSTEM (K003873)Mentor Corp.2001-03-29
THE O'NEIL STERILE FIELD URINARY CATHETER KIT (K002803)Go Medical Industries Pty. , Ltd.2000-12-27
SELF CATH SET/SAFETY CATH (K983010)Rusch Intl.1999-02-12
RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET (K963993)Rusch, Inc.1996-12-17
NHMC URETHRAL CATHETERIZATION TRAY (K962254)National Healthcare Mfg. Corp.1996-07-29
URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY (K962073)Continental Medical Laboratories, Inc.1996-06-21
UNIVERSAL DRAINAGE TRAY (K961442)Customed, Inc.1996-05-09
CPR FOLEY CAHTETER KIT (K960214)Custom Pack Reliability1996-04-01
CPR URETHRAL CATHETER TRAY (K960215)Custom Pack Reliability1996-04-01
NHMC FOLEY CATHETERIZATION TRAY (K960566)National Healthcare Mfg. Corp.1996-02-29
CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE (K951479)Trinity Laboratories, Inc.1995-06-15
URETHRAL CATHETERIZATION TRAY (K950390)Medcare Custom Packaging, Inc.1995-05-30
UROLOGICAL CATHETER & ACCESSORIES (K951178)Deroyal Industries, Inc.1995-04-21
HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER (K950344)Acacia Laboratories, Inc.1995-03-24
CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY (K950092)Cypress Medical Products, Ltd.1995-02-27
CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER (K950109)Cypress Medical Products, Ltd.1995-02-27
FOLEY CATHETERIZATION TRAY (K942177)Customed, Inc.1994-09-08
MON-A-THERM FOLEY KIT (K923538)Mallinckrodt Medical1993-05-27
TOUCHLESS II INTERMITTENT CATHETER (K910653)C.R. Bard, Inc.1991-05-06
MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT (K910022)Medical Marketing Group1991-04-02
ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY (K904158)Welcon, Inc.1990-11-29
STERILE URETHRAL CATHETER PROCEDURE KITS (K903340)Superior Healthcare Group, Inc.1990-10-04
LAKE MALE EXTERNAL CATHETERIZATION KIT (K902508)Lake Medical Products, Inc.1990-08-23
FOLEY CATHETER INSERTION TRAY (10CC) (K901185)Orion Life Systems, Inc.1990-07-20
CATHETER CARE TRAY (K901181)Orion Life Systems, Inc.1990-07-20
URETHRAL CATHETER TRAY (PVC) (K901183)Orion Life Systems, Inc.1990-07-20
URETHRAL CATHETER TRAY (LATEX) (K901184)Orion Life Systems, Inc.1990-07-20
FOLEY CATHETER INSERTION TRAY (30CC) (K901180)Orion Life Systems, Inc.1990-07-20
URETHRAL CATHETERIZATION TRAYS (K896212)Westmark, Sterile Packing Systems, Inc. (Sps)1990-01-24
FOLEY CATHETERIZATION TRAY (K790254)Snyder Laboratories, Inc.1979-04-10
TRAY AND BAG, CATHETERIZATION (K790271)Snyder Laboratories, Inc.1979-03-06
TRAY, URETHRAL CATHETERIZATION (K790272)Snyder Laboratories, Inc.1979-03-06
URETHRO CATHETERIZATION TRAY (K780879)Abco Dealers, Inc.1978-07-31
URINARY CATHETER CARE SET (K780735)Shield Laboratories, Inc.1978-06-13
BLADDER RETENTION-CATHETHERIZATIONTRAY (K772277)Latex Ind., Inc.1978-03-02
CATHETERIZATION KIT 732016-732018 (K772340)Latex Ind., Inc.1978-02-24
ROBINSON KIT - 750014 & 750016 (K772342)Latex Ind., Inc.1978-02-24
BLADDER CATH KIT W/OUT CATHETER (K780268)Latex Ind., Inc.1978-02-24
BLADDER KIT - 734000 (K772341)Latex Ind., Inc.1978-02-24
CATHETERIZATION PROCED. TRAY, URETHRAL (K780124)Walpak Co.1978-02-21
CATHETERIZATION PROCEDURE TRAY (K780123)Walpak Co.1978-02-21
AKRO-SIL FOLEY KIT 5CC (K771651)Latex Ind., Inc.1977-09-20
CATH-CARE TRAY (K771652)Latex Ind., Inc.1977-09-20
AKRO-SIL FOLEY KIT 30CC (K771650)Latex Ind., Inc.1977-09-20
URETHRAL TRAY W/CATHETER, 7750 (K771103)Concord Laboratories, Inc.1977-06-24
URETHRAL TRAY W/OUT CAHTETER, 7650 (K771104)Concord Laboratories, Inc.1977-06-24
UNIVERSAL TRAY (K770496)Concord Laboratories, Inc.1977-03-21
TRAY, URETHRAL CATHETERIZATION (K760048)M-C Ind., Inc.1977-03-01
TRAY, CATHETERIZATION W/O CATHETER (K760127)Concord Laboratories, Inc.1976-10-07
TRAY, CATHETERIZATION W/ CATHETER (K760128)Concord Laboratories, Inc.1976-10-07

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