FDA product code · Neurology · Class 2
POL: Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
POL is FDA's product code for "Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment": a Class 2 device classified under 21 CFR 882.5600, reviewed by the Neurology panel.
510(k) review time for POL
Across 16 510(k) clearances under POL decided from 2018-01-01 to 2026-10-06, the median was 122 days from FDA receipt to decision. Half took between 98 and 175 days, and 80% were decided within 175 days. These are past clearances, not a forecast for a new submission.
| Fastest | 17 |
|---|---|
| 25th percentile | 98 |
| Median | 122 |
| 75th percentile | 175 |
| 80th percentile | 175 |
| 90th percentile | 215 |
| Slowest | 333 |
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 POL
No FDA recognized consensus standard cites POL 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.