FDA Product Code PYT: Device, Fertility Diagnostic, Contraceptive, Software Application
Designed To Monitor And Provide Fertility Information To Prevent Pregnancy (contraception).
Leading manufacturers include Natural Cycles Nordic AB and Biowink GmbH.
FDA 510(k) Cleared Device, Fertility Diagnostic, Contraceptive, Software Application Devices (Product Code PYT)
About Product Code PYT - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code PYT since 2018, with 5 receiving FDA clearance (average review time: 211 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PYT have taken an average of 57 days to reach a decision - down from 288 days historically, suggesting improved FDA processing for this classification.
PYT devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →