Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart B — Diagnostic Devices](/submissions/GU/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 876.1400](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1400) → FFT — Electrode, Ph, Stomach # FFT · Electrode, Ph, Stomach _Gastroenterology, Urology · 21 CFR 876.1400 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT ## Overview - **Product Code:** FFT - **Device Name:** Electrode, Ph, Stomach - **Regulation:** [21 CFR 876.1400](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1400) - **Device Class:** 1 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) ## Identification A stomach pH electrode is a device used to measure intragastric and intraesophageal pH (hydrogen ion concentration). The pH electrode is at the end of a flexible lead which may be inserted into the esophagus or stomach through the patient's mouth. The device may include an integral gastrointestinal tube. ## Classification Rationale Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. ## Recent Cleared Devices (20 of 49) Showing 20 most recent of 49 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K102543](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K102543.md) | BRAVO PH MONITORING SYSTEM AND ACCESSORIES | Given Imaging , Ltd. | Dec 1, 2010 | SESE | | [K013951](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K013951.md) | SANDHILL SCIENTIFIC PEDIATEC PH PROBE | Sandhill Scientific, Inc. | Feb 28, 2002 | SESE | | [K002028](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K002028.md) | BRAVO PH MONITORING SYSTEM | Endonetics, Inc. | Sep 29, 2000 | SESE | | [K961346](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K961346.md) | PH ANALYSIS MODULE | Synectics-Dantec | Jan 29, 1997 | SESE | | [K950087](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K950087.md) | LOT 440 | Medical Instruments Corporation Mic AG | Feb 6, 1996 | SESE | | [K955018](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K955018.md) | TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR | Instrumentarium Corp. | Jan 30, 1996 | SESE | | [K945069](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K945069.md) | FLEXILOG 2000 | Oakfield Instruments, Ltd. | Jun 13, 1995 | SESE | | [K920849](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K920849.md) | TRIP CIC CATHETER | Tonometrics, Inc. | Mar 17, 1995 | SESE | | [K934434](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K934434.md) | CYBERRX MODEL 7200 | Cybermed Control Systems, Inc. | Jan 24, 1995 | SESE | | [K925405](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K925405.md) | ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. | Synectics-Dantec | Sep 30, 1994 | SESE | | [K931963](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K931963.md) | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE | Sandhill Scientific, Inc. | Sep 28, 1994 | SESE | | [K913817](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K913817.md) | MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION | Synectics-Dantec | Jun 11, 1992 | SESE | | [K914624](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K914624.md) | PH METER, MODIFICATION | Synectics-Dantec | Apr 28, 1992 | SESE | | [K912772](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K912772.md) | SUPERLOGGER | Sandhill Scientific, Inc. | Feb 7, 1992 | SESE | | [K913387](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K913387.md) | DIGITRAPPER MARK III | Synectics-Dantec | Dec 27, 1991 | SESE | | [K911825](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K911825.md) | TRIP(TM) NASOGASTRIC SUMP CATHETER | Tonometrics, Inc. | Jul 23, 1991 | SESE | | [K910694](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K910694.md) | ZINETICS INTERNAL REFERENCE PROBE | Zinetics Medical, Inc. | May 17, 1991 | SESE | | [K903646](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K903646.md) | GASTROGRAPH | Medics Instrument Corp. | Nov 5, 1990 | SESE | | [K902366](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K902366.md) | MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT | Synectics-Dantec | Jun 8, 1990 | SESE | | [K896288](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT/K896288.md) | FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM | Oakfield Instruments, Ltd. | May 4, 1990 | SESE | ## Top Applicants - Synectics-Dantec — 10 clearances - Diamond Medical, Inc. — 4 clearances - Sandhill Scientific, Inc. — 4 clearances - Tonometrics, Inc. — 3 clearances - Biosearch Medical Products, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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