FDA Product Code SHR:
Leading manufacturers include Hjarta Care, LLC.
1
Total
0
Cleared
253d
Avg days
2026
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared SHR Devices (Product Code SHR)
1 devices
About Product Code SHR - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SHR since 2026, with 0 receiving FDA clearance (average review time: 253 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.
SHR devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →