PYT · Class II · 21 CFR 884.5370

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.

6
Total
5
Cleared
211d
Avg days
2018
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 24d recently vs 248d historically

FDA 510(k) Cleared Device, Fertility Diagnostic, Contraceptive, Software Application Devices (Product Code PYT)

6 devices
1–6 of 6
Cleared Mar 21, 2025
Natural Cycles
K250561
Natural Cycles Nordic AB
Obstetrics & Gynecology · 24d
Cleared Jul 11, 2024
Natural Cycles
K241006
Natural Cycles Nordic AB
Obstetrics & Gynecology · 90d
Cleared Aug 24, 2023
Natural Cycles
K231274
Natural Cycles Nordic AB
Obstetrics & Gynecology · 114d
Cleared Jun 24, 2021
Natural Cycles
K202897
Natural Cycles Nordic AB
Obstetrics & Gynecology · 268d
Cleared Feb 18, 2021
Clue Birth Control
K193330
Biowink GmbH
Obstetrics & Gynecology · 444d
Not Cleared Aug 10, 2018
Natural Cycles
DEN170052
Natural Cycles Nordic AB
Obstetrics & Gynecology · 324d

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 declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - PYT Product Code

Recent submissions under PYT have taken an average of 24 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 →