Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - ONN Product Code

Recent submissions under ONN have taken an average of 105 days to reach a decision - down from 204 days historically, suggesting improved FDA processing for this classification.

ONN devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,218 total devices indexed.

Latest clearance: Jun 02, 2026

Product Code Info

Code	ONN
Device class	Class II
CFR	21 CFR 882.4560
Panel	Orthopedic

Verify on FDA.gov

View ONN classification on FDA.gov →