FDA product code · Ear, Nose, Throat · Class 2
PFO: Active Implantable Bone Conduction Hearing System
PFO is FDA's product code for "Active Implantable Bone Conduction Hearing System": a Class 2 device classified under 21 CFR 874.3340, reviewed by the Ear, Nose, Throat panel.
510(k) review time for PFO
Across 11 510(k) clearances under PFO decided from 2018-01-01 to 2026-10-06, the median was 114 days from FDA receipt to decision. Half took between 101 and 119 days, and 80% were decided within 120 days. These are past clearances, not a forecast for a new submission.
| Fastest | 84 |
|---|---|
| 25th percentile | 101 |
| Median | 114 |
| 75th percentile | 119 |
| 80th percentile | 120 |
| 90th percentile | 127 |
| Slowest | 149 |
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 PFO
No FDA recognized consensus standard cites PFO 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.