FDA product code · Radiology · Class 2
POK: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
POK is FDA's product code for "Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer": a Class 2 device classified under 21 CFR 892.2060, reviewed by the Radiology panel.
510(k) review time for POK
Across 22 510(k) clearances under POK decided from 2018-01-01 to 2026-10-06, the median was 146 days from FDA receipt to decision. Half took between 103 and 189 days, and 80% were decided within 201 days. These are past clearances, not a forecast for a new submission.
| Fastest | 25 |
|---|---|
| 25th percentile | 103 |
| Median | 146 |
| 75th percentile | 189 |
| 80th percentile | 201 |
| 90th percentile | 215 |
| Slowest | 268 |
| Year | Median days | n |
|---|---|---|
| 2024 | 161 | 6 |
| 2025 | 119 | 5 |
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 POK
No FDA recognized consensus standard cites POK 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.