FDA product code · Neurology · Class 2
PCC: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
PCC is FDA's product code for "Stimulator, Nerve, Electrical, Transcutaneous, For Migraine": a Class 2 device classified under 21 CFR 882.5891, reviewed by the Neurology panel.
510(k) review time for PCC
Across 14 510(k) clearances under PCC decided from 2018-01-01 to 2026-10-06, the median was 119 days from FDA receipt to decision. Half took between 84 and 261 days, and 80% were decided within 303 days. These are past clearances, not a forecast for a new submission.
| Fastest | 27 |
|---|---|
| 25th percentile | 84 |
| Median | 119 |
| 75th percentile | 261 |
| 80th percentile | 303 |
| 90th percentile | 379 |
| Slowest | 529 |
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.
FDA-recognized standards that cite PCC
No FDA recognized consensus standard cites PCC 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.