FDA Product Code SHW:
Leading manufacturers include Artera, Inc. and SimBioSys, Inc..
2
Total
2
Cleared
200d
Avg days
2026
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared SHW Devices (Product Code SHW)
2 devices
Cleared
Sep 25, 2026
TumorSight Risk
SimBioSys, Inc.
Pathology
263d
Cleared
May 04, 2026
ArteraAI Breast
Artera, Inc.
Pathology
136d
About Product Code SHW - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SHW since 2026, with 2 receiving FDA clearance (average review time: 200 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.