FDA Product Code SIA:
Leading manufacturers include Visby Medical, Inc..
1
Total
1
Cleared
167d
Avg days
2026
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared SIA Devices (Product Code SIA)
1 devices
About Product Code SIA - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SIA since 2026, with 1 receiving FDA clearance (average review time: 167 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.