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.
7
Total
6
Cleared
215d
Avg days
2018
Since
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg
131d
recently vs 248d historically
FDA 510(k) Cleared Device, Fertility Diagnostic, Contraceptive, Software Application Devices (Product Code PYT)
7 devices
Cleared
Mar 21, 2025
Natural Cycles
Natural Cycles Nordic AB
Obstetrics & Gynecology
24d
Cleared
Jul 11, 2024
Natural Cycles
Natural Cycles Nordic AB
Obstetrics & Gynecology
90d
Cleared
Aug 24, 2023
Natural Cycles
Natural Cycles Nordic AB
Obstetrics & Gynecology
114d
Cleared
Jun 24, 2021
Natural Cycles
Natural Cycles Nordic AB
Obstetrics & Gynecology
268d
Cleared
Feb 18, 2021
Clue Birth Control
Biowink GmbH
Obstetrics & Gynecology
444d
Not Cleared
Aug 10, 2018
Natural Cycles
Natural Cycles Nordic AB
Obstetrics & Gynecology
324d
About Product Code PYT - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code PYT since 2018, with 6 receiving FDA clearance (average review time: 215 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - PYT Product Code
Recent submissions under PYT have taken an average of 131 days to reach a decision - down from 248 days historically, suggesting improved FDA processing for this classification.
PYT devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →