FDA Product Code JWO: Device, Blood Volume Measuring
Leading manufacturers include Daxor Corporation.
3
Total
3
Cleared
173d
Avg days
1997
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
97d
recently vs 325d historically
FDA 510(k) Cleared Device, Blood Volume Measuring Devices (Product Code JWO)
3 devices
About Product Code JWO - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code JWO since 1997, with 3 receiving FDA clearance (average review time: 173 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.
FDA 510(k) Review Time - JWO Product Code
Recent submissions under JWO have taken an average of 97 days to reach a decision - down from 325 days historically, suggesting improved FDA processing for this classification.
JWO devices are reviewed by the Hematology panel. Browse all Hematology devices →