FDA product code FFT: Electrode, Ph, Stomach
FFT is the FDA product code for electrode, ph, stomach. It is a Class I device, regulated under 21 CFR 876.1400 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 49 510(k) submissions under FFT, from 28 different applicants. The average 510(k) review took 171 days (median 91). FDA has posted 10 recalls for FFT devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Ph, Stomach |
| Device class | Class I |
| Regulation | 21 CFR 876.1400 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Top FFT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synectics-Dantec | 10 | 1997-01-29 |
| Sandhill Scientific, Inc. | 4 | 2002-02-28 |
| Diamond Medical, Inc. | 4 | 1988-02-08 |
| Tonometrics, Inc. | 3 | 1995-03-17 |
| Oakfield Instruments, Ltd. | 2 | 1995-06-13 |
23 more applicants have FFT clearances. See the full list in Caduvo.
Most recent FFT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K102543 | Given Imaging , Ltd. | BRAVO PH MONITORING SYSTEM AND ACCESSORIES | 2010-12-01 | 89 |
| K013951 | Sandhill Scientific, Inc. | SANDHILL SCIENTIFIC PEDIATEC PH PROBE | 2002-02-28 | 90 |
| K002028 | Endonetics, Inc. | BRAVO PH MONITORING SYSTEM | 2000-09-29 | 88 |
| K961346 | Synectics-Dantec | PH ANALYSIS MODULE | 1997-01-29 | 320 |
| K950087 | Medical Instruments Corporation Mic AG | LOT 440 | 1996-02-06 | 392 |
Recalls for FFT devices
10 product recalls in 8 recall events; 1 initiated in the last five years and 3 still open. Most recent: 2025-06-03.
| Year | Recalls |
|---|---|
| 2021 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code FFT?
FFT is the FDA product code for electrode, ph, stomach. It is a Class I device, regulated under 21 CFR 876.1400 and reviewed by the Gastroenterology and Urology panel.
What device class is FFT?
Class I, regulation 21 CFR 876.1400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FFT?
Across 49 cleared submissions the average was 171 days from receipt to decision (median 91).
Which companies have the most FFT clearances?
Synectics-Dantec (10); Sandhill Scientific, Inc. (4); Diamond Medical, Inc. (4); Tonometrics, Inc. (3); Oakfield Instruments, Ltd. (2).
Have FFT devices been recalled?
Yes: 10 product recalls across 8 recall events; the most recent began 2025-06-03.
Next steps
- Run an FDA pathway report with predicate devices for product code FFT
- Run a recall and safety report across every FFT manufacturer
- Watch product code FFT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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