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FDA product code · Gastroenterology, Urology · Class 2

FFX: System, Gastrointestinal Motility (Electrical)

FFX is FDA's product code for "System, Gastrointestinal Motility (Electrical)": a Class 2 device classified under 21 CFR 876.1725, reviewed by the Gastroenterology, Urology panel.

510(k) review time for FFX

Across 11 510(k) clearances under FFX decided from 2018-01-01 to 2026-10-06, the median was 125 days from FDA receipt to decision. Half took between 106 and 217 days, and 80% were decided within 238 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, FFX, decisions 2018-01-01 to 2026-10-06 (n = 11)
Fastest27
25th percentile106
Median125
75th percentile217
80th percentile238
90th percentile241
Slowest401

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

FFX in the public FDA record

Records naming FFX, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years69
Device recalls7
GUDID device identifiers1,348

Counts of records, not of devices or events. Adverse event reports for FFX are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite FFX

No FDA recognized consensus standard cites FFX by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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