FDA product code · Anesthesiology · Class 2
KOI: Stimulator, Nerve, Peripheral, Electric
KOI is FDA's product code for "Stimulator, Nerve, Peripheral, Electric": a Class 2 device classified under 21 CFR 868.2775, reviewed by the Anesthesiology panel.
510(k) review time for KOI
Across 13 510(k) clearances under KOI decided from 2018-01-01 to 2026-10-06, the median was 191 days from FDA receipt to decision. Half took between 108 and 241 days, and 80% were decided within 257 days. These are past clearances, not a forecast for a new submission.
| Fastest | 50 |
|---|---|
| 25th percentile | 108 |
| Median | 191 |
| 75th percentile | 241 |
| 80th percentile | 257 |
| 90th percentile | 273 |
| Slowest | 293 |
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.
KOI in the public FDA record
| Establishment listings | 125 |
|---|
Counts of records, not of devices or events. Adverse event reports for KOI 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 KOI
No FDA recognized consensus standard cites KOI 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.