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: FKP FDA class 2

System, Dialysate Delivery, Single Patient

Gastroenterology, Urology

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The Single-Patient Dialysate Delivery System is a machine or system that prepares and delivers dialysate solution to an individual patient's hemodialysis circuit during treatment. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKP, regulated under 21 CFR 876.5820 in the Gastroenterology and Urology specialty. This device is designated as life sustaining or life supporting.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K181991

NxStage Connected Health System

Sep 26, 2018

Substantially Equivalent

NxStage Medical, Inc

K131739

NXSTAGE CONNECTED HEALTH SYSTEM

Oct 10, 2013

Substantially Equivalent

NXSTAGE MEDICAL, INC.

K130460

NXSTAGE DOSING CALCULATOR

Jul 11, 2013

Substantially Equivalent

NXSTAGE MEDICAL, INC.

K040074

ONEVIEW INTERFACE

Apr 08, 2004

Substantially Equivalent

NXSTAGE MEDICAL, INC.

K021060

FRESENIUS ICARE MONITORING SYSTEM

Nov 13, 2002

Substantially Equivalent

FRESENIUS MEDICAL CARE NORTH AMERICA

K003615

STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS

Feb 01, 2001

Substantially Equivalent

ENVIRONMENTAL TEST SYSTEMS, INC.

K992255

CKHEMO, MODEL CKHEMO VERSION 1.0

Nov 30, 1999

Substantially Equivalent

CSAM, INC.

K964264

HIGH RANGE PEROXIDE TEST STRIP

Jun 16, 1997

Substantially Equivalent

INTEGRATED BIOMEDICAL TECHNOLOGY, INC.

K955423

PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM

Jun 13, 1996

Substantially Equivalent

FRESENIUS USA, INC.

K953854

WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE

Mar 11, 1996

Substantially Equivalent

INTEGRATED BIOMEDICAL TECHNOLOGY, INC.

K930181

BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE

Nov 29, 1995

Substantially Equivalent

FRESENIUS USA, INC.

K922757

SPS 1550 SINGLE NEEDLE PATIENT SYSTEM

Feb 13, 1995

Substantially Equivalent

BAXTER HEALTHCARE CORP.

K921456

FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM

Apr 20, 1994

Substantially Equivalent

FRESENIUS USA, INC.

K910215

DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST

Apr 09, 1991

Substantially Equivalent

CD MEDICAL, INC.

K905793

COBE CENTRY 2 BICART OPTION KIT

Feb 12, 1991

Substantially Equivalent

COBE LABORATORIES, INC.

K905388

COBE CENTRYSYSTEM 3 BICART OPTION KIT

Feb 11, 1991

Substantially Equivalent

COBE LABORATORIES, INC.

K904967

HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL

Jan 28, 1991

Substantially Equivalent

GAMBRO-HOSP-COBE, INC.

K896758

GAMBRO BICARBONATE MONITOR BCM 10-3

Sep 28, 1990

Substantially Equivalent

GAMBRO, INC.

K896757

GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS

Aug 30, 1990

Substantially Equivalent

GAMBRO, INC.

K894838

HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB

Sep 07, 1989

Substantially Equivalent

BAXTER HEALTHCARE CORP.

K890824

FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM

May 11, 1989

Substantially Equivalent

FRESENIUS USA, INC.

K883111

HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650

Feb 08, 1989

Substantially Equivalent

BAXTER HEALTHCARE CORP.

K880459

480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE

Apr 13, 1988

Substantially Equivalent

CD MEDICAL, INC.

K873155

GAMBRO BICART SYSTEM

Oct 26, 1987

Substantially Equivalent

GAMBRO, INC.

K871218

MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT

Apr 30, 1987

Substantially Equivalent

HOSPAL MEDICAL CORP.

K863609

SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22

Feb 25, 1987

Substantially Equivalent

INTERNATIONAL MEDICAL PRODUCTS, INC.

K864094

GAMBRO FLUID CONTROL MONITOR FCM 10-1

Nov 07, 1986

Substantially Equivalent

GAMBRO, INC.

K864083

GAMBRO BICARBONATE MONITOR BCM 10-2

Nov 06, 1986

Substantially Equivalent

GAMBRO, INC.

K861230

MONITRAL S

Apr 25, 1986

Substantially Equivalent

HOSPAL MEDICAL CORP.

K854367

HD-SECURA HEMADIALYSIS MACHINE

Dec 16, 1985

Substantially Equivalent

ORGANON TEKNIKA CORP.

K854479

BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH

Dec 16, 1985

Substantially Equivalent

NIPRO COMPANY, LTD.

K853513

DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY

Nov 06, 1985

Substantially Equivalent

CD MEDICAL, INC.

K851306

COBE SYSTEM 3

Jun 12, 1985

Substantially Equivalent

COBE LABORATORIES, INC.

K850569

BSM 2000 DIALYSIS MACHINE - MODIFIED

Mar 12, 1985

Substantially Equivalent

ORGANON TEKNIKA CORP.

K850179

MBM(TM) MONITRAL (R) BICARBONATE MODULE

Feb 28, 1985

Substantially Equivalent

HOSPAL MEDICAL CORP.

K813432

HEMODIALYSIS SYSTEM

Jun 23, 1982

Substantially Equivalent

FHK

K811972

EXTRASENSR ULTRAFILTRATION MONITOR

Nov 16, 1981

Substantially Equivalent

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

K811591

B-D DRAKE WILLOCK #7000 SERIES ULTRAF

Jul 10, 1981

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

K802880

EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS

Dec 17, 1980

Substantially Equivalent

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

K802250

DIALYSIS CONTROL UNIT-CENTRY 2000

Dec 10, 1980

Substantially Equivalent

COBE LABORATORIES, INC.

K800330

MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM

Apr 08, 1980

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

K800425

GAMBRO AK-10-UDM-10-A ULTRADIFFUSION

Apr 08, 1980

Substantially Equivalent

GAMBRO, INC.

K792173

MODELS DM-360 & DM-350-L SINGLE PATIENT

Nov 16, 1979

Substantially Equivalent

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

K781886

DIALYSATE DELIVERY SYSTEM

Jan 17, 1979

Substantially Equivalent

CORDIS CORP.

K781405

SUITCASE KIDNEY HEMODIALYSIS SYSTEM

Dec 07, 1978

Substantially Equivalent

UNION CARBIDE CORP.

K780682

SINGLE PATIENT SYSTEMS

Jun 22, 1978

Substantially Equivalent

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

K771696

EMODIALYSIS DEL. SYS. MODEL 7110

Sep 15, 1977

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

K771065

DYLADE, MODEL DS

Jun 24, 1977

Substantially Equivalent

MILTON ROY CO. ANALYTICAL

K770350

DIALYSIS DELIVERY SYS., ULTIM. MODEL II

Mar 08, 1977

Substantially Equivalent

VITAL SYSTEMS, INC.

K761287

5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY

Jan 03, 1977

Substantially Equivalent

TRAVENOL LABORATORIES, S.A.

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

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