FDA Product Code PBH: Embryo Image Assessment System, Assisted Reproduction
The Device Will Obtain And Analyze Light Microscopy Images Of Developing Embryos. This Device Provides Information To Aid In The Selection Of Embryo(s) For Transfer When There Are Multiple Embryos Deemed Suitable For Transfer Or Freezing .
Leading manufacturers include Fairtility , Ltd..
FDA 510(k) Cleared Embryo Image Assessment System, Assisted Reproduction Devices (Product Code PBH)
About Product Code PBH - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code PBH since 2014, with 3 receiving FDA clearance (average review time: 324 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 PBH have taken an average of 242 days to reach a decision - down from 351 days historically, suggesting improved FDA processing for this classification.
PBH devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →