Atlas FDA

KNX

206 FDA 510(k) clearances · Product code

46 daysmedian time to decision
121 days90th percentile
206clearances measured

FDA profile

Official device name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5250
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2021: 209 · 2022: 167 · 2023: 178 · 2024: 162 · 2025: 200 · 2026: 138
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
IBAG (K110518)Future Path Medical, LLC2011-06-24
4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG (K973364)Maersk Medical A/S1998-03-17
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG (K972887)Medline Industries, Inc.1997-12-11
BESECURE EXTERNAL URINARY COLLECTION SYSTEM (K971271)Urology Research Intl., Inc.1997-08-18
AMSINO URINARY LEG BAG (K971929)Amsino Intl., Inc.1997-08-06
WELCON HUE-VU URINARY DRAINAGE BAG (K971764)Welcon, Inc.1997-07-29
LIBERTY VALVE (K964690)Cleveland Medical Devices, Inc.1997-03-21
AMSINO URINARY DRAINAGE BAG (K964745)Amsino Intl., Inc.1997-03-18
URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (K962652)Customed, Inc.1996-10-04
PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (K960949)Bristol-Myers Squibb1996-04-19
PROSYS LEG BAG (K952208)Convatec, A Division of E.R. Squibb & Sons1995-08-15
ORION'S URINARY DRAINAGE SET (K944377)Regulatory & Marketing Services, Inc.1994-12-06
NEEDLELESS URINE SAMPLING PORT (K944236)Kendall Healthcare Products Co. Div.Of Tyco Health1994-11-16
BARD URINE COLLECTION PRODUCTS MODIFICATION (K940206)C.R. Bard, Inc.1994-09-16
SIMPLA S4, S5, S7 (K941447)Simpla Plastics , Ltd.1994-07-18
URINARY DRAINAGE BAG (K935557)Puritas Health Care, Inc.1994-03-07
KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER (K931459)Kendall Healthcare Products Co. Div.Of Tyco Health1993-06-14
SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG (K925067)Simport Plastics, Ltd.1993-06-10
HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878 (K926570)Hollister, Inc.1993-05-21
URO-TOTE LEG BAG (K921024)Neotech Products, Inc.1992-09-02
BODEN WHEELCHAIR DRAINAGE SYSTEM (K913142)Mno Medical Products1991-09-23
STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES (K913223)Medical Device Inspection Co., Inc.1991-09-04
ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG (K901320)Ep Medical, Inc.1991-01-25
BAG, URINE (K902417)Gainor Medical Europe, Ltd.1990-07-16
URINE COLLECTOR LEG BAG (K896688)Medline Industries, Inc.1990-05-02
URO-BAGGIE (K895168)Cwt Workshop1990-03-22
4 SURE URINARY DRAIN BAG (K896727)The Boston & Pacific Co., Inc.1990-02-20
GOOSEN URINARY DRAINAGE SYSTEM (K896579)Goosen Enterprises, Inc.1990-02-15
L.T.C. 1000 URINARY DRAINAGE BAG (K895957)Intl. Medical Marketing, Inc.1989-10-24
KENDALL KENGUARD URINARY LEG BAGS (K892437)The Kendal Co.1989-06-23
KENDALL CURITY URINARY DRAINAGE BAGS (K892433)The Kendal Co.1989-05-05
URINARY DRAINAGE UNIT (K890551)Consolidated Products & Services, Inc.1989-02-28
CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE) (K890550)Consolidated Products & Services, Inc.1989-02-28
SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP (K881678)Hollister, Inc.1988-08-11
GENT-L-KARE STERILE URINARY LEG BAG (K881217)Geneva Laboratories, Inc.1988-07-29
GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER (K881213)Geneva Laboratories, Inc.1988-07-28
CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT (K880034)Lin-Mark, Inc.1988-03-02
URETHAL CATHETER (K874309)Medovations, Inc.1987-12-07
P. URINE METER, 250CC (K872824)Ni-Med, Inc.1987-10-14
MMG CATH-N-PLACE (K873136)Medical Technologies of Georgia1987-09-09
CONVEEN(R) LEG-BAG (600 ML) (K871643)Coloplast A/S1987-06-10
CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML) (K871610)Coloplast A/S1987-06-10
SECOND NATURE(TM) (K871387)Advanced Clinical Products, Inc.1987-05-29
NORTA (TM) UROBAG (K870504)Beiersdorf, Inc.1987-04-01
URINE METER, 250CC (K871042)Salt Creek Medical Technologies1987-03-25
E-Z HOLD WITH ADHESIVE BASE.-#4065 (K864188)John F. Greer Co., Inc.1986-12-04
BESCURE (K863739)U-T, Inc.1986-10-24
PENNINE LEG BAG 350ML CAT.NO.DB3 & 500ML.CAT.#DB5 (K863671)Samco Industries, Inc.1986-10-03
NEPHROSTOMY CONNECTING TUBE (A-50) (K862581)Advanced Clinical Products, Inc.1986-09-23
NEPHROSTOMY DRAINAGE KIT (A-150) (K862580)Advanced Clinical Products, Inc.1986-09-23
MODIFIED BIO-FLOW MODEL 200 URINE FLOW DEVICE (K862251)Bio-Flow, Inc.1986-09-04
HOLLISTER FEMALE URINARY COLLECTION POUCH (K862934)Hollister, Inc.1986-08-19
SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER (K860362)Travenol Laboratories, S.A.1986-04-29
MMG EXTERNAL FEMALE CATHETERS (K854821)Medical Technologies of Georgia1986-04-24
GENTLE BACK, PLASTIC URINARY DRAINAGE BAG (K861192)Advanced Clinical Products, Inc.1986-04-23
AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N (K861251)American Medical Products, Inc.1986-04-17
NIR LAT MALE EXTERNAL CATHETER (K855209)Mali, Inc.1986-01-10
CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH (K854580)Coloplast A/S1985-12-13
VISTA MED-URISTAT (K853892)Vista Med1985-12-02
URINARY DRAINAGE BAG (K854480)The West Co., Inc.1985-11-19
URI-CATH SYSTEM (K852490)Gesco Intl., Inc.1985-11-05
UCD URINE SPECIMEN COLLECTOR (K854173)Baker Instructions Corp.1985-11-04
URI-SURE (K852619)Ashai Co. , Ltd.1985-08-27
H-H SEXTON SCUP URINE MGMT. SYS (K853458)Holter-Hausner Intl.1985-08-27
EXTERNAL MALE CATHETER (K852051)Buffalo Medical Specialties Mfg., Inc.1985-08-22
KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG (K852085)The Kendal Co.1985-08-07
NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG (K844810)C.R. Bard, Inc.1985-07-24
SAFESTRETCH INCONTINENCE SYSTEM (K851681)Dbt Medical , Ltd.1985-06-28
QRI-FLOW URINE FLOW MEASURING DEVICE (K851266)Bio-Flow, Inc.1985-06-27
BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR (K851470)Lic-Orthion1985-06-12
TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR (K851471)Lic-Orthion1985-06-12
STANDARD URINARY DRAINAGE BAG & LEG BAG (K844155)Norris W. Whitlock1985-01-16
ULTRA EXTERNAL CATHETER (K844801)Inmed Corp.1985-01-15
COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM (K844684)Coloplast A/S1985-01-08
FEMALE URINARY INCONTINENCE SYS (K843128)Chesebrough-Pond'S U.S.A. Co.1985-01-02
TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE (K844280)Travenol Laboratories, S.A.1984-12-17
CLOSED URINARY DRAINAGE UNIT (K843698)Pathfinder Intl. Corp.1984-12-17
PHARMA-PLAST URIDROP-URIDOME (K843478)Zimmar Consulting , Ltd.1984-12-05
PHARMA-PLAST CONNECTING TUBE TYPE URIN- (K843481)Zimmar Consulting , Ltd.1984-10-18
PHARMA-PLAST LEG BAG (K843479)Zimmar Consulting , Ltd.1984-10-11
PHARMA-PLAST URINARY DRAINAGE BAG 2000 (K843480)Zimmar Consulting , Ltd.1984-10-11
GREEN CROSS URINARY DRAINAGE BAG (K843117)Tech-Cons Ltd., Intl.1984-10-11
MEDIFLEX DRAINAGE BAG (K843126)Mediflex Intl.1984-10-04
ACCUSEAL LEG BAGS & EXTENSION TUBES (K842396)Convatec, A Division of E.R. Squibb & Sons1984-08-08
CORPAK URINARY DRAINAGE BAG (K842257)Corpak Co.1984-08-08
URIHESIVE SYS MALE EXTERNAL CATHETER (K842397)Convatec, A Division of E.R. Squibb & Sons1984-08-08
SUR-FIT NIGHT DRAINAGE CONTAINER SET (K842395)Convatec, A Division of E.R. Squibb & Sons1984-08-08
CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE (K832290)Travenol Laboratories, S.A.1984-07-31
CHESEBROUGH-POND'S REUSABLE URINARY LEG (K842553)Chesebrough-Pond'S U.S.A. Co.1984-07-20
CYSTO-AID (K841197)E-Z-Em, Inc.1984-07-09
CURITY RIG FOLEY CATH TRAY (K841169)The Kendal Co.1984-07-06
URO-MALE INCONTINENCE CATHETER (K841224)Gil-Med Industries C/O Kegan & Kegan, Ltd.1984-05-02
URINARY MONITORING SYS 240 (K840917)Vital Metrics, Inc.1984-05-01
MULTIPLE SYS-URINE DRAINAGE-CLOSED (K840284)Luth Corp.1984-04-13
MULTIPLE BAG, LEG (K840283)Luth Corp.1984-04-13
SECURE W/35MM DIAM, SHEATH/ADHESIVE (K840704)Warne Surgical Products, Ltd.1984-03-22
SECURE W/30MM DIAM, SHEATH & ADHESIVE (K840703)Warne Surgical Products, Ltd.1984-03-22
SECURE W/25MM DIAM. SHEATH & ADHESIVE (K840702)Warne Surgical Products, Ltd.1984-03-22
URETHRAL CATH. TRAY W/BAG (K840292)Corpak Co.1984-03-16
URIHESIVE SYSTEM - IMPROVED (K834337)Convatec, A Division of E.R. Squibb & Sons1984-02-10
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