Product code KNX— Gastroenterology, Urology
URINARY DRAINAGE BAG
- Classification name
- Collector, Urine, (And Accessories) For Indwelling Catheter
- Device class
- Class 2
- Regulation
- 21 CFR 876.5250
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 206
- First cleared
- Most recent
Market context for product code KNX
FDA has cleared devices under product code KNX between 1976 and 2011, filed by 112 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2011
- 1998
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
Top applicants under product code KNX
Adverse events under product code KNX
product code KNX- Malfunction
- 1,064
- Total
- 1,064
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KNX
1–100 of 206- K110518 — IBAG
- K973364 — 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG
- K972887 — MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
- K971271 — BESECURE EXTERNAL URINARY COLLECTION SYSTEM
- K971929 — AMSINO URINARY LEG BAG
- K971764 — WELCON HUE-VU URINARY DRAINAGE BAG
- K964690 — LIBERTY VALVE
- K964745 — AMSINO URINARY DRAINAGE BAG
- K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
- K960949 — PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167
- K952208 — PROSYS LEG BAG
- K944377 — ORION'S URINARY DRAINAGE SET
- K944236 — NEEDLELESS URINE SAMPLING PORT
- K940206 — BARD URINE COLLECTION PRODUCTS MODIFICATION
- K941447 — SIMPLA S4, S5, S7
- K935557 — URINARY DRAINAGE BAG
- K931459 — KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER
- K925067 — SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG
- K926570 — HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878
- K921024 — URO-TOTE LEG BAG
- K913142 — BODEN WHEELCHAIR DRAINAGE SYSTEM
- K913223 — STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES
- K901320 — ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG
- K902417 — BAG, URINE
- K896688 — URINE COLLECTOR LEG BAG
- K895168 — URO-BAGGIE
- K896727 — 4 SURE URINARY DRAIN BAG
- K896579 — GOOSEN URINARY DRAINAGE SYSTEM
- K895957 — L.T.C. 1000 URINARY DRAINAGE BAG
- K892437 — KENDALL KENGUARD URINARY LEG BAGS
- K892433 — KENDALL CURITY URINARY DRAINAGE BAGS
- K890550 — CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE)
- K890551 — URINARY DRAINAGE UNIT
- K881678 — SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP
- K881217 — GENT-L-KARE STERILE URINARY LEG BAG
- K881213 — GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER
- K880034 — CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT
- K874309 — URETHAL CATHETER
- K872824 — P. URINE METER, 250CC
- K873136 — MMG CATH-N-PLACE
- K871610 — CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)
- K871643 — CONVEEN(R) LEG-BAG (600 ML)
- K871387 — SECOND NATURE(TM)
- K870504 — NORTA (TM) UROBAG
- K871042 — URINE METER, 250CC
- K864188 — E-Z HOLD WITH ADHESIVE BASE.-#4065
- K863739 — BESCURE
- K863671 — PENNINE LEG BAG 350ML CAT.NO.DB3 & 500ML.CAT.#DB5
- K862580 — NEPHROSTOMY DRAINAGE KIT (A-150)
- K862581 — NEPHROSTOMY CONNECTING TUBE (A-50)
- K862251 — MODIFIED BIO-FLOW MODEL 200 URINE FLOW DEVICE
- K862934 — HOLLISTER FEMALE URINARY COLLECTION POUCH
- K860362 — SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
- K854821 — MMG EXTERNAL FEMALE CATHETERS
- K861192 — GENTLE BACK, PLASTIC URINARY DRAINAGE BAG
- K861251 — AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N
- K855209 — NIR LAT MALE EXTERNAL CATHETER
- K854580 — CONVEEN SELF-SEALING URISHEATH MALE EXTERNAL CATH
- K853892 — VISTA MED-URISTAT
- K854480 — URINARY DRAINAGE BAG
- K852490 — URI-CATH SYSTEM
- K854173 — UCD URINE SPECIMEN COLLECTOR
- K852619 — URI-SURE
- K853458 — H-H SEXTON SCUP URINE MGMT. SYS
- K852051 — EXTERNAL MALE CATHETER
- K852085 — KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG
- K844810 — NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG
- K851681 — SAFESTRETCH INCONTINENCE SYSTEM
- K851266 — QRI-FLOW URINE FLOW MEASURING DEVICE
- K851470 — BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR
- K851471 — TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR
- K844155 — STANDARD URINARY DRAINAGE BAG & LEG BAG
- K844801 — ULTRA EXTERNAL CATHETER
- K844684 — COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM
- K843128 — FEMALE URINARY INCONTINENCE SYS
- K843698 — CLOSED URINARY DRAINAGE UNIT
- K844280 — TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE
- K843478 — PHARMA-PLAST URIDROP-URIDOME
- K843481 — PHARMA-PLAST CONNECTING TUBE TYPE URIN-
- K843117 — GREEN CROSS URINARY DRAINAGE BAG
- K843479 — PHARMA-PLAST LEG BAG
- K843480 — PHARMA-PLAST URINARY DRAINAGE BAG 2000
- K843126 — MEDIFLEX DRAINAGE BAG
- K842257 — CORPAK URINARY DRAINAGE BAG
- K842395 — SUR-FIT NIGHT DRAINAGE CONTAINER SET
- K842396 — ACCUSEAL LEG BAGS & EXTENSION TUBES
- K842397 — URIHESIVE SYS MALE EXTERNAL CATHETER
- K832290 — CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE
- K842553 — CHESEBROUGH-POND'S REUSABLE URINARY LEG
- K841197 — CYSTO-AID
- K841169 — CURITY RIG FOLEY CATH TRAY
- K841224 — URO-MALE INCONTINENCE CATHETER
- K840917 — URINARY MONITORING SYS 240
- K840283 — MULTIPLE BAG, LEG
- K840284 — MULTIPLE SYS-URINE DRAINAGE-CLOSED
- K840702 — SECURE W/25MM DIAM. SHEATH & ADHESIVE
- K840703 — SECURE W/30MM DIAM, SHEATH & ADHESIVE
- K840704 — SECURE W/35MM DIAM, SHEATH/ADHESIVE
- K840292 — URETHRAL CATH. TRAY W/BAG
- K834337 — URIHESIVE SYSTEM - IMPROVED
Data sourced from openFDA. This site is unofficial and independent of the FDA.