Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

FFT — Predicate Candidate Screening

49 FDA 510(k) clearances under this product code; the 50 most recent screened below.

91 daysmedian FDA review time

392 days90th percentile

49clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K102543	BRAVO PH MONITORING SYSTEM AND ACCESSORIES	Given Imaging , Ltd.	2010-12-01	89	2
K013951	SANDHILL SCIENTIFIC PEDIATEC PH PROBE	Sandhill Scientific, Inc.	2002-02-28	90	0
K002028	BRAVO PH MONITORING SYSTEM	Endonetics, Inc.	2000-09-29	88	4
K961346	PH ANALYSIS MODULE	Synectics-Dantec	1997-01-29	320	0
K950087	LOT 440	Medical Instruments Corporation Mic AG	1996-02-06	392	0
K955018	TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR	Instrumentarium Corp.	1996-01-30	89	0
K945069	FLEXILOG 2000	Oakfield Instruments, Ltd.	1995-06-13	242	0
K920849	TRIP CIC CATHETER	Tonometrics, Inc.	1995-03-17	1116	0
K934434	CYBERRX MODEL 7200	Cybermed Control Systems, Inc.	1995-01-24	519	0
K925405	ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.	Synectics-Dantec	1994-09-30	704	0
K931963	SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE	Sandhill Scientific, Inc.	1994-09-28	525	2
K913817	MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION	Synectics-Dantec	1992-06-11	290	0
K914624	PH METER, MODIFICATION	Synectics-Dantec	1992-04-28	195	0
K912772	SUPERLOGGER	Sandhill Scientific, Inc.	1992-02-07	228	0
K913387	DIGITRAPPER MARK III	Synectics-Dantec	1991-12-27	151	0
K911825	TRIP(TM) NASOGASTRIC SUMP CATHETER	Tonometrics, Inc.	1991-07-23	90	0
K910694	ZINETICS INTERNAL REFERENCE PROBE	Zinetics Medical, Inc.	1991-05-17	87	0
K903646	GASTROGRAPH	Medics Instrument Corp.	1990-11-05	83	0
K902366	MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT	Synectics-Dantec	1990-06-08	23	0
K896288	FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM	Oakfield Instruments, Ltd.	1990-05-04	186	0
K883960	GIPHY MONITOR	Vascular Technology Incorporated	1989-10-04	379	0
K891410	NASOGASTRIC PH SUCTION CATHETER, ST-5001	Sensatronix Medical Systems, Inc.	1989-06-23	101	0
K883234	TONOMITOR (TM) + SUMP	Tonometrics, Inc.	1988-10-12	72	0
K881706	PROXIMA 1 PH MONITOR	Technomanagement, Inc. C/O C.G.	1988-07-12	84	0
K874709	DIAMOND MEDICAL, INC. MODEL DM 800	Diamond Medical, Inc.	1988-02-08	88	0
K874710	DIAMOND MEDICAL, INC. MODEL DM 600	Diamond Medical, Inc.	1988-02-08	88	0
K875369	MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT	Diamond Medical, Inc.	1988-02-05	36	0
K871922	PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA.	Chemfet Corp.	1987-10-20	155	0
K871921	GENERAL PURPOSE COMBINATION PH ELECTRODE	Chemfet Corp.	1987-10-20	155	0
K872929	PH MONITORING SYSTEM	Sensatronix Medical Systems, Inc.	1987-08-10	14	0
K871282	SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE	Synectics-Dantec	1987-06-10	71	0
K870606	TONOMITOR(TM)	Tonometrics Holdings SA C/O Mackeen Consultants	1987-04-10	58	0
K863298	DIAMOND MEDICAL, INC., MODEL DM 700	Diamond Medical, Inc.	1987-03-17	204	0
K862727	ZINETICS GASTROMETER (TM)	Zinetics Medical Technology Corp.	1986-11-19	124	0
K862929	SYNECTICS MOTILITY SYSTEM	Synectics-Dantec	1986-10-20	89	0
K862536	MODEL 1010 AMBULATORY PH MONITORING SYSTEM	Oxford Medilog, Inc.	1986-09-12	72	0
K854514	AMBI-24 PH/PRESSURE MONITOR	Biosearch Medical Products, Inc.	1986-02-24	104	0
K853280	FOUR CHANNEL PH PROBE	Akron City Hospital	1985-12-02	119	0
K853648	SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO	Synectics-Dantec	1985-11-18	76	0
K852289	MODEL SA3 ESOPHAGEAL PH ELECTRODE	World Precision Instruments, Inc.	1985-07-25	57	0
K850778	SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE	Settler Medical Electronics, Inc.	1985-06-13	107	0
K850361	SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E	Synectics-Dantec	1985-05-01	91	0
K850074	ESOPHOGEAL PH CATHETER	Biosearch Medical Products, Inc.	1985-02-14	36	0
K842690	SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT	Synectics AB	1984-11-08	121	0
K841384	PROXIMA 1 PH MONITOR	American Endoscopy, Inc.	1984-07-19	121	0
K834512	SANDMILL RMS	Sandhill Scientific, Inc.	1984-02-21	62	0
K822815	MODEL 700 GASTROREFLUX MONITOR/AMALYZER	Del Mar Avionics	1982-10-22	32	0
K820566	PATIENT ISOLATOR #S-10/D-10	Microelectrodes, Inc.	1982-03-23	21	0
K811083	ESOPHAGEAL MOTILITY PROBE	Konigsberg Instruments, Inc.	1981-08-13	114	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda