PYT — Device, Fertility Diagnostic, Contraceptive, Software Application Class II
FDA product code PYT covers "Device, Fertility Diagnostic, Contraceptive, Software Application", a Class II medical device regulated under 21 CFR 884.5370. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PYT
- Device Class
- Class II
- Regulation Number
- 884.5370
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
Designed to monitor and provide fertility information to prevent pregnancy (contraception).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250561 | natural cycles nordic | Natural Cycles | March 21, 2025 |
| K241006 | natural cycles nordic | Natural Cycles | July 11, 2024 |
| K231274 | natural cycles nordic | Natural Cycles | August 24, 2023 |
| K202897 | natural cycles nordic | Natural Cycles | June 24, 2021 |
| K193330 | biowink | Clue Birth Control | February 18, 2021 |
| DEN170052 | natural cycles nordic | Natural Cycles | August 10, 2018 |