FDA Product Code JWO: Device, Blood Volume Measuring
Leading manufacturers include Daxor Corporation.
FDA 510(k) Cleared Device, Blood Volume Measuring Devices (Product Code JWO)
About Product Code JWO - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code JWO since 1997, with 2 receiving FDA clearance (average review time: 221 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.
FDA Review Time
Recent submissions under JWO have taken an average of 117 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 →