Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: KNX FDA class 2

Collector, Urine, (And Accessories) For Indwelling Catheter

Gastroenterology, Urology

View full classification →

A Urine Collector with Accessories for Indwelling Catheter is a closed drainage system used in clinical settings to collect and contain urine from patients with indwelling urinary catheters, helping to maintain a sterile, closed circuit that reduces the risk of catheter-associated urinary tract infections. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KNX and the applicable regulation is 21 CFR 876.5250 in the Gastroenterology and Urology specialty.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K110518

IBAG

Jun 24, 2011

Substantially Equivalent

FUTURE PATH MEDICAL, LLC

K973364

4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG

Mar 17, 1998

Substantially Equivalent

MAERSK MEDICAL A/S

K972887

MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG

Dec 11, 1997

Substantially Equivalent

MEDLINE INDUSTRIES, INC.

K971271

BESECURE EXTERNAL URINARY COLLECTION SYSTEM

Aug 18, 1997

Substantially Equivalent

UROLOGY RESEARCH INTL., INC.

K971929

AMSINO URINARY LEG BAG

Aug 06, 1997

Substantially Equivalent

AMSINO INTL., INC.

K971764

WELCON HUE-VU URINARY DRAINAGE BAG

Jul 29, 1997

Substantially Equivalent

WELCON, INC.

K964690

LIBERTY VALVE

Mar 21, 1997

Substantially Equivalent

CLEVELAND MEDICAL DEVICES, INC.

K964745

AMSINO URINARY DRAINAGE BAG

Mar 18, 1997

Substantially Equivalent

AMSINO INTL., INC.

K962652

URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)

Oct 04, 1996

Substantially Equivalent

CUSTOMED, INC.

K960949

PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167

Apr 19, 1996

Substantially Equivalent

BRISTOL-MYERS SQUIBB

K952208

PROSYS LEG BAG

Aug 15, 1995

Substantially Equivalent

CONVATEC, A DIVISION OF E.R. SQUIBB & SONS

K944377

ORION'S URINARY DRAINAGE SET

Dec 06, 1994

Substantially Equivalent

REGULATORY & MARKETING SERVICES, INC.

K944236

NEEDLELESS URINE SAMPLING PORT

Nov 16, 1994

Substantially Equivalent

KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH

K940206

BARD URINE COLLECTION PRODUCTS MODIFICATION

Sep 16, 1994

Substantially Equivalent

C.R. BARD, INC.

K941447

SIMPLA S4, S5, S7

Jul 18, 1994

Substantially Equivalent

SIMPLA PLASTICS LTD.

K935557

URINARY DRAINAGE BAG

Mar 07, 1994

Substantially Equivalent

PURITAS HEALTH CARE, INC.

K931459

KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER

Jun 14, 1993

Substantially Equivalent

KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH

K925067

SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG

Jun 10, 1993

Substantially Equivalent

SIMPORT PLASTICS LTD

K926570

HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878

May 21, 1993

Substantially Equivalent

HOLLISTER, INC.

K921024

URO-TOTE LEG BAG

Sep 02, 1992

Substantially Equivalent

NEOTECH PRODUCTS, INC.

K913142

BODEN WHEELCHAIR DRAINAGE SYSTEM

Sep 23, 1991

Substantially Equivalent

MNO MEDICAL PRODUCTS

K913223

STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES

Sep 04, 1991

Substantially Equivalent

MEDICAL DEVICE INSPECTION CO., INC.

K901320

ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG

Jan 25, 1991

Substantially Equivalent

EP MEDICAL, INC.

K902417

BAG, URINE

Jul 16, 1990

Substantially Equivalent

GAINOR MEDICAL EUROPE, LTD.

K896688

URINE COLLECTOR LEG BAG

May 02, 1990

Substantially Equivalent

MEDLINE INDUSTRIES, INC.

K895168

URO-BAGGIE

Mar 22, 1990

Substantially Equivalent

CWT WORKSHOP

K896727

4 SURE URINARY DRAIN BAG

Feb 20, 1990

Substantially Equivalent

THE BOSTON & PACIFIC CO., INC.

K896579

GOOSEN URINARY DRAINAGE SYSTEM

Feb 15, 1990

Substantially Equivalent

GOOSEN ENTERPRISES, INC.

K895957

L.T.C. 1000 URINARY DRAINAGE BAG

Oct 24, 1989

Substantially Equivalent

INTL. MEDICAL MARKETING, INC.

K892437

KENDALL KENGUARD URINARY LEG BAGS

Jun 23, 1989

Substantially Equivalent

THE KENDAL CO.

K892433

KENDALL CURITY URINARY DRAINAGE BAGS

May 05, 1989

Substantially Equivalent

THE KENDAL CO.

K890551

URINARY DRAINAGE UNIT

Feb 28, 1989

Substantially Equivalent

CONSOLIDATED PRODUCTS & SERVICES, INC.

K890550

CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE)

Feb 28, 1989

Substantially Equivalent

CONSOLIDATED PRODUCTS & SERVICES, INC.

K881678

SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP

Aug 11, 1988

Substantially Equivalent

HOLLISTER, INC.

K881217

GENT-L-KARE STERILE URINARY LEG BAG

Jul 29, 1988

Substantially Equivalent

GENEVA LABORATORIES, INC.

K881213

GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER

Jul 28, 1988

Substantially Equivalent

GENEVA LABORATORIES, INC.

K880034

CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT

Mar 02, 1988

Substantially Equivalent

LIN-MARK, INC.

K874309

URETHAL CATHETER

Dec 07, 1987

Substantially Equivalent

MEDOVATIONS, INC.

K872824

P. URINE METER, 250CC

Oct 14, 1987

Substantially Equivalent

NI-MED, INC.

K873136

MMG CATH-N-PLACE

Sep 09, 1987

Substantially Equivalent

MEDICAL TECHNOLOGIES OF GEORGIA

K871610

CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)

Jun 10, 1987

Substantially Equivalent

COLOPLAST A/S

K871643

CONVEEN(R) LEG-BAG (600 ML)

Jun 10, 1987

Substantially Equivalent

COLOPLAST A/S

K871387

SECOND NATURE(TM)

May 29, 1987

Substantially Equivalent

ADVANCED CLINICAL PRODUCTS, INC.

K870504

NORTA (TM) UROBAG

Apr 01, 1987

Substantially Equivalent

BEIERSDORF, INC.

K871042

URINE METER, 250CC

Mar 25, 1987

Substantially Equivalent

SALT CREEK MEDICAL TECHNOLOGIES

K864188

E-Z HOLD WITH ADHESIVE BASE.-#4065

Dec 04, 1986

Substantially Equivalent

JOHN F. GREER CO., INC.

K863739

BESCURE

Oct 24, 1986

Substantially Equivalent

U-T, INC.

K863671

PENNINE LEG BAG 350ML CAT.NO.DB3 & 500ML.CAT.#DB5

Oct 03, 1986

Substantially Equivalent

SAMCO INDUSTRIES, INC.

K862580

NEPHROSTOMY DRAINAGE KIT (A-150)

Sep 23, 1986

Substantially Equivalent

ADVANCED CLINICAL PRODUCTS, INC.

K862581

NEPHROSTOMY CONNECTING TUBE (A-50)

Sep 23, 1986

Substantially Equivalent

ADVANCED CLINICAL PRODUCTS, INC.

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

Popular Product Codes

Commonly searched

DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump