FDA product code FFX: System, Gastrointestinal Motility (Electrical)
FFX is the FDA product code for system, gastrointestinal motility (electrical). It is a Class II device, regulated under 21 CFR 876.1725 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 69 510(k) submissions under FFX, 5 in the last five years, from 36 different applicants. The average 510(k) review took 179 days (median 109); 117 days on average over the last three years. FDA has posted 7 recalls for FFX devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Gastrointestinal Motility (Electrical) |
| 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 |
510(k) clearances per year for FFX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 216 |
| 2018 | 1 | 136 |
| 2019 | 4 | 246 |
| 2020 | 1 | 27 |
| 2023 | 3 | 115 |
| 2024 | 1 | 125 |
| 2025 | 1 | 109 |
Compare with all 510(k) review times · Search every FFX clearance
Top FFX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Crospon, Ltd. | 7 | 2019-02-15 |
| Medtronic Functional Diagnostics A/S | 7 | 2002-11-08 |
| Sandhill Scientific, Inc. | 6 | 2002-06-07 |
| Medical Measurement Systems B.V. | 5 | 2012-08-01 |
| Mui Scientific | 4 | 2017-03-14 |
31 more applicants have FFX clearances. See the full list in Caduvo.
Most recent FFX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252605 | Medspira, LLC | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | 2025-12-05 | 109 |
| K240007 | Laborie Medical Technologies, Corp. | Solar Compact (G4-1) | 2024-05-06 | 125 |
| K231861 | Covidien, LLC | EndoflipTM 300 System | 2023-07-21 | 28 |
| K223705 | Covidien, LLC | EndoflipTM 300 | 2023-04-14 | 123 |
| K222000 | Medifactia AB | Transit-Pellets | 2023-01-18 | 195 |
Recalls for FFX devices
7 product recalls in 7 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-05-21.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code FFX?
FFX is the FDA product code for system, gastrointestinal motility (electrical). It is a Class II device, regulated under 21 CFR 876.1725 and reviewed by the Gastroenterology and Urology panel.
What device class is FFX?
Class II, regulation 21 CFR 876.1725. Typical premarket route: 510(k).
How long does a 510(k) take for product code FFX?
Across 69 cleared submissions the average was 179 days from receipt to decision (median 109).
Which companies have the most FFX clearances?
Crospon, Ltd. (7); Medtronic Functional Diagnostics A/S (7); Sandhill Scientific, Inc. (6); Medical Measurement Systems B.V. (5); Mui Scientific (4).
Have FFX devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2026-05-21.
Next steps
- Run an FDA pathway report with predicate devices for product code FFX
- Run a recall and safety report across every FFX manufacturer
- Watch product code FFX 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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