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FDA product code · Gastroenterology, Urology · Class 2

KPI: Stimulator, Electrical, Non-Implantable, For Incontinence

KPI is FDA's product code for "Stimulator, Electrical, Non-Implantable, For Incontinence": a Class 2 device classified under 21 CFR 876.5320, reviewed by the Gastroenterology, Urology panel.

510(k) review time for KPI

Across 30 510(k) clearances under KPI decided from 2018-01-01 to 2026-10-06, the median was 198 days from FDA receipt to decision. Half took between 154 and 265 days, and 80% were decided within 268 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, KPI, decisions 2018-01-01 to 2026-10-06 (n = 30)
Fastest67
25th percentile154
Median198
75th percentile265
80th percentile268
90th percentile271
Slowest422

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.

KPI in the public FDA record

Records naming KPI, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years96

Counts of records, not of devices or events. Adverse event reports for KPI 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 KPI

No FDA recognized consensus standard cites KPI 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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