Atlas FDA

FFT

49 FDA 510(k) clearances · Product code

91 daysmedian time to decision
392 days90th percentile
49clearances measured

FDA profile

Official device name
Electrode, Ph, Stomach
Device class
Class I (low risk)
Regulation
21 CFR 876.1400
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2021: 516 · 2022: 260 · 2023: 259 · 2024: 239 · 2025: 594 · 2026: 362
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BRAVO PH MONITORING SYSTEM AND ACCESSORIES (K102543)Given Imaging , Ltd.2010-12-01
SANDHILL SCIENTIFIC PEDIATEC PH PROBE (K013951)Sandhill Scientific, Inc.2002-02-28
BRAVO PH MONITORING SYSTEM (K002028)Endonetics, Inc.2000-09-29
PH ANALYSIS MODULE (K961346)Synectics-Dantec1997-01-29
LOT 440 (K950087)Medical Instruments Corporation Mic AG1996-02-06
TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR (K955018)Instrumentarium Corp.1996-01-30
FLEXILOG 2000 (K945069)Oakfield Instruments, Ltd.1995-06-13
TRIP CIC CATHETER (K920849)Tonometrics, Inc.1995-03-17
CYBERRX MODEL 7200 (K934434)Cybermed Control Systems, Inc.1995-01-24
ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. (K925405)Synectics-Dantec1994-09-30
SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (K931963)Sandhill Scientific, Inc.1994-09-28
MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION (K913817)Synectics-Dantec1992-06-11
PH METER, MODIFICATION (K914624)Synectics-Dantec1992-04-28
SUPERLOGGER (K912772)Sandhill Scientific, Inc.1992-02-07
DIGITRAPPER MARK III (K913387)Synectics-Dantec1991-12-27
TRIP(TM) NASOGASTRIC SUMP CATHETER (K911825)Tonometrics, Inc.1991-07-23
ZINETICS INTERNAL REFERENCE PROBE (K910694)Zinetics Medical, Inc.1991-05-17
GASTROGRAPH (K903646)Medics Instrument Corp.1990-11-05
MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT (K902366)Synectics-Dantec1990-06-08
FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM (K896288)Oakfield Instruments, Ltd.1990-05-04
GIPHY MONITOR (K883960)Vascular Technology Incorporated1989-10-04
NASOGASTRIC PH SUCTION CATHETER, ST-5001 (K891410)Sensatronix Medical Systems, Inc.1989-06-23
TONOMITOR (TM) + SUMP (K883234)Tonometrics, Inc.1988-10-12
PROXIMA 1 PH MONITOR (K881706)Technomanagement, Inc. C/O C.G.1988-07-12
DIAMOND MEDICAL, INC. MODEL DM 800 (K874709)Diamond Medical, Inc.1988-02-08
DIAMOND MEDICAL, INC. MODEL DM 600 (K874710)Diamond Medical, Inc.1988-02-08
MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT (K875369)Diamond Medical, Inc.1988-02-05
PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA. (K871922)Chemfet Corp.1987-10-20
GENERAL PURPOSE COMBINATION PH ELECTRODE (K871921)Chemfet Corp.1987-10-20
PH MONITORING SYSTEM (K872929)Sensatronix Medical Systems, Inc.1987-08-10
SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE (K871282)Synectics-Dantec1987-06-10
TONOMITOR(TM) (K870606)Tonometrics Holdings SA C/O Mackeen Consultants1987-04-10
DIAMOND MEDICAL, INC., MODEL DM 700 (K863298)Diamond Medical, Inc.1987-03-17
ZINETICS GASTROMETER (TM) (K862727)Zinetics Medical Technology Corp.1986-11-19
SYNECTICS MOTILITY SYSTEM (K862929)Synectics-Dantec1986-10-20
MODEL 1010 AMBULATORY PH MONITORING SYSTEM (K862536)Oxford Medilog, Inc.1986-09-12
AMBI-24 PH/PRESSURE MONITOR (K854514)Biosearch Medical Products, Inc.1986-02-24
FOUR CHANNEL PH PROBE (K853280)Akron City Hospital1985-12-02
SYNECTICS LIBERTY SYS COMPRIS DIGITRAPPER MK II MO (K853648)Synectics-Dantec1985-11-18
MODEL SA3 ESOPHAGEAL PH ELECTRODE (K852289)World Precision Instruments, Inc.1985-07-25
SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE (K850778)Settler Medical Electronics, Inc.1985-06-13
SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E (K850361)Synectics-Dantec1985-05-01
ESOPHOGEAL PH CATHETER (K850074)Biosearch Medical Products, Inc.1985-02-14
SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT (K842690)Synectics AB1984-11-08
PROXIMA 1 PH MONITOR (K841384)American Endoscopy, Inc.1984-07-19
SANDMILL RMS (K834512)Sandhill Scientific, Inc.1984-02-21
MODEL 700 GASTROREFLUX MONITOR/AMALYZER (K822815)Del Mar Avionics1982-10-22
PATIENT ISOLATOR #S-10/D-10 (K820566)Microelectrodes, Inc.1982-03-23
ESOPHAGEAL MOTILITY PROBE (K811083)Konigsberg Instruments, Inc.1981-08-13

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Every clearance here is in the API, with alerts when new ones post.