Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - PZO Product Code

Recent submissions under PZO have taken an average of 114 days to reach a decision - down from 202 days historically, suggesting improved FDA processing for this classification.

PZO devices are reviewed by the Neurology panel. Browse all Neurology devices →

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,450 total devices indexed.

Latest clearance: Dec 23, 2025

Product Code Info

Code	PZO
Device class	Class II
CFR	21 CFR 892.2050
Panel	Neurology

Verify on FDA.gov

View PZO classification on FDA.gov →