Product Code: FFT FDA class 1 21 CFR 876.1400

Electrode, Ph, Stomach

Gastroenterology, Urology

The Stomach pH Electrode is a diagnostic device inserted into the stomach to measure intragastric acidity, used in the evaluation of gastroesophageal reflux disease and other acid-related conditions. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket notification requirement. The product code is FFT, regulated under 21 CFR 876.1400, within the Gastroenterology, Urology medical specialty.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: FFT
Device Class: FDA class 1
Regulation Number: 876.1400
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 49 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K102543	BRAVO PH MONITORING SYSTEM AND ACCESSORIES	Dec 01, 2010	Substantially Equivalent	Given Imaging , Ltd.
K013951	SANDHILL SCIENTIFIC PEDIATEC PH PROBE	Feb 28, 2002	Substantially Equivalent	Sandhill Scientific, Inc.
K002028	BRAVO PH MONITORING SYSTEM	Sep 29, 2000	Substantially Equivalent	Endonetics, Inc.
K961346	PH ANALYSIS MODULE	Jan 29, 1997	Substantially Equivalent	Synectics-Dantec
K950087	LOT 440	Feb 06, 1996	Substantially Equivalent	Medical Instruments Corporation Mic AG
K955018	TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR	Jan 30, 1996	Substantially Equivalent	Instrumentarium Corp.
K945069	FLEXILOG 2000	Jun 13, 1995	Substantially Equivalent	Oakfield Instruments, Ltd.
K920849	TRIP CIC CATHETER	Mar 17, 1995	Substantially Equivalent	Tonometrics, Inc.
K934434	CYBERRX MODEL 7200	Jan 24, 1995	Substantially Equivalent	Cybermed Control Systems, Inc.
K925405	ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.	Sep 30, 1994	Substantially Equivalent	Synectics-Dantec
K931963	SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE	Sep 28, 1994	Substantially Equivalent	Sandhill Scientific, Inc.
K913817	MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION	Jun 11, 1992	Substantially Equivalent	Synectics-Dantec
K914624	PH METER, MODIFICATION	Apr 28, 1992	Substantially Equivalent	Synectics-Dantec
K912772	SUPERLOGGER	Feb 07, 1992	Substantially Equivalent	Sandhill Scientific, Inc.
K913387	DIGITRAPPER MARK III	Dec 27, 1991	Substantially Equivalent	Synectics-Dantec
K911825	TRIP(TM) NASOGASTRIC SUMP CATHETER	Jul 23, 1991	Substantially Equivalent	Tonometrics, Inc.
K910694	ZINETICS INTERNAL REFERENCE PROBE	May 17, 1991	Substantially Equivalent	Zinetics Medical, Inc.
K903646	GASTROGRAPH	Nov 05, 1990	Substantially Equivalent	Medics Instrument Corp.
K902366	MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT	Jun 08, 1990	Substantially Equivalent	Synectics-Dantec
K896288	FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM	May 04, 1990	Substantially Equivalent	Oakfield Instruments, Ltd.
K883960	GIPHY MONITOR	Oct 04, 1989	Substantially Equivalent	Vascular Technology Incorporated
K891410	NASOGASTRIC PH SUCTION CATHETER, ST-5001	Jun 23, 1989	Substantially Equivalent	Sensatronix Medical Systems, Inc.
K883234	TONOMITOR (TM) + SUMP	Oct 12, 1988	Substantially Equivalent	Tonometrics, Inc.
K881706	PROXIMA 1 PH MONITOR	Jul 12, 1988	Substantially Equivalent	Technomanagement, Inc. C/O C.G.
K874710	DIAMOND MEDICAL, INC. MODEL DM 600	Feb 08, 1988	Substantially Equivalent	Diamond Medical, Inc.
K874709	DIAMOND MEDICAL, INC. MODEL DM 800	Feb 08, 1988	Substantially Equivalent	Diamond Medical, Inc.
K875369	MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT	Feb 05, 1988	Substantially Equivalent	Diamond Medical, Inc.
K871922	PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA.	Oct 20, 1987	Substantially Equivalent	Chemfet Corp.
K871921	GENERAL PURPOSE COMBINATION PH ELECTRODE	Oct 20, 1987	Substantially Equivalent	Chemfet Corp.
K872929	PH MONITORING SYSTEM	Aug 10, 1987	Substantially Equivalent	Sensatronix Medical Systems, Inc.
K871282	SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE	Jun 10, 1987	Substantially Equivalent	Synectics-Dantec
K870606	TONOMITOR(TM)	Apr 10, 1987	Substantially Equivalent	Tonometrics Holdings SA C/O Mackeen Consultants
K863298	DIAMOND MEDICAL, INC., MODEL DM 700	Mar 17, 1987	Substantially Equivalent	Diamond Medical, Inc.
K862727	ZINETICS GASTROMETER (TM)	Nov 19, 1986	Substantially Equivalent	Zinetics Medical Technology Corp.
K862929	SYNECTICS MOTILITY SYSTEM	Oct 20, 1986	Substantially Equivalent	Synectics-Dantec
K862536	MODEL 1010 AMBULATORY PH MONITORING SYSTEM	Sep 12, 1986	Substantially Equivalent	Oxford Medilog, Inc.
K854514	AMBI-24 PH/PRESSURE MONITOR	Feb 24, 1986	Substantially Equivalent	Biosearch Medical Products, Inc.
K853280	FOUR CHANNEL PH PROBE	Dec 02, 1985	Substantially Equivalent	Akron City Hospital
K853648	SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO	Nov 18, 1985	Substantially Equivalent	Synectics-Dantec
K852289	MODEL SA3 ESOPHAGEAL PH ELECTRODE	Jul 25, 1985	Substantially Equivalent	World Precision Instruments, Inc.
K850778	SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE	Jun 13, 1985	Substantially Equivalent	Settler Medical Electronics, Inc.
K850361	SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E	May 01, 1985	Substantially Equivalent	Synectics-Dantec
K850074	ESOPHOGEAL PH CATHETER	Feb 14, 1985	Substantially Equivalent	Biosearch Medical Products, Inc.
K842690	SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT	Nov 08, 1984	Substantially Equivalent	Synectics AB
K841384	PROXIMA 1 PH MONITOR	Jul 19, 1984	Substantially Equivalent	American Endoscopy, Inc.
K834512	SANDMILL RMS	Feb 21, 1984	Substantially Equivalent	Sandhill Scientific, Inc.
K822815	MODEL 700 GASTROREFLUX MONITOR/AMALYZER	Oct 22, 1982	Substantially Equivalent	Del Mar Avionics
K820566	PATIENT ISOLATOR #S-10/D-10	Mar 23, 1982	Substantially Equivalent	Microelectrodes, Inc.
K811083	ESOPHAGEAL MOTILITY PROBE	Aug 13, 1981	Substantially Equivalent	Konigsberg Instruments, Inc.