FDA Product Code PBZ: Image Processing Device For Estimation Of External Blood Loss
An Image Processing Device For Estimation Of External Blood Loss Is A Device To Be Used As An Aid In Estimation Of Patient External Blood Loss. The Device May Include Software And/or Hardware That Is Used To Process Images Capturing Externally Lost Blood To Estimate The Hemoglobin Mass And/or The Blood Volume Present In The Images.
Leading manufacturers include Stryker Instruments.
6
Total
5
Cleared
223d
Avg days
2014
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times:
237d avg (recent)
FDA 510(k) Cleared Image Processing Device For Estimation Of External Blood Loss Devices (Product Code PBZ)
6 devices
Cleared
Mar 16, 2026
SurgiCount+ System
Stryker Instruments
Obstetrics & Gynecology
237d
Cleared
Jan 11, 2024
SurgiCount+ System
Stryker Instruments
General & Plastic Surgery
167d
About Product Code PBZ - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code PBZ since 2014, with 5 receiving FDA clearance (average review time: 223 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - PBZ Product Code
FDA review times for PBZ submissions have been consistent, averaging 237 days recently vs 220 days historically.
PBZ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →