FDA product code FES: Recorder, External, Pressure, Amplifier & Transducer
FES is the FDA product code for recorder, external, pressure, amplifier & transducer. It is a Class II device, regulated under 21 CFR 876.1725 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FES, from 2 different applicants. The average 510(k) review took 80 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Recorder, External, Pressure, Amplifier & Transducer |
| Device class | Class II |
| Regulation | 21 CFR 876.1725 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FES clearance
Top FES applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ferguson Medical | 1 | 1989-05-30 |
| Medical Measurements, Inc. | 1 | 1980-08-27 |
Most recent FES clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890284 | Ferguson Medical | URODEC 500 | 1989-05-30 | 131 |
| K801757 | Medical Measurements, Inc. | MMI/GAELTEC CATHETER TIP PRESS. TRANSDU | 1980-08-27 | 30 |
Recalls for FES devices
openFDA lists no recalls for product code FES.
Frequently asked questions
What is FDA product code FES?
FES is the FDA product code for recorder, external, pressure, amplifier & transducer. It is a Class II device, regulated under 21 CFR 876.1725 and reviewed by the Gastroenterology and Urology panel.
What device class is FES?
Class II, regulation 21 CFR 876.1725. Typical premarket route: 510(k).
How long does a 510(k) take for product code FES?
Across 2 cleared submissions the average was 80 days from receipt to decision (median 80).
Which companies have the most FES clearances?
Ferguson Medical (1); Medical Measurements, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FES
- Run a recall and safety report across every FES manufacturer
- Watch product code FES 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.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times