FDA Product Code SHM:
Leading manufacturers include Steris.
1
Total
0
Cleared
505d
Avg days
2026
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared SHM Devices (Product Code SHM)
1 devices
About Product Code SHM - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SHM since 2026, with 0 receiving FDA clearance (average review time: 505 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.
SHM devices are reviewed by the General Hospital panel. Browse all General Hospital devices →