FDA product code PYT: Device, Fertility Diagnostic, Contraceptive, Software Application
PYT is the FDA product code for device, fertility diagnostic, contraceptive, software application. It is a Class II device, regulated under 21 CFR 884.5370 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 6 510(k) submissions under PYT, 4 in the last five years, from 2 different applicants. The average 510(k) review took 196 days (median 176); 117 days on average over the last three years. 1 De Novo request was granted under it.
Definition
Designed to monitor and provide fertility information to prevent pregnancy (contraception).
Classification
| Field | Value |
|---|---|
| Device name | Device, Fertility Diagnostic, Contraceptive, Software Application |
| Device class | Class II |
| Regulation | 21 CFR 884.5370 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for PYT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 2 | 356 |
| 2023 | 1 | 114 |
| 2024 | 1 | 90 |
| 2025 | 1 | 24 |
| 2026 | 1 | 238 |
Compare with all 510(k) review times · Search every PYT clearance
Top PYT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Natural Cycles Nordic AB | 5 | 2026-07-17 |
| Biowink GmbH | 1 | 2021-02-18 |
Most recent PYT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253694 | Natural Cycles Nordic AB | Natural Cycles | 2026-07-17 | 238 |
| K250561 | Natural Cycles Nordic AB | Natural Cycles | 2025-03-21 | 24 |
| K241006 | Natural Cycles Nordic AB | Natural Cycles | 2024-07-11 | 90 |
| K231274 | Natural Cycles Nordic AB | Natural Cycles | 2023-08-24 | 114 |
| K202897 | Natural Cycles Nordic AB | Natural Cycles | 2021-06-24 | 268 |
Recalls for PYT devices
openFDA lists no recalls for product code PYT.
Frequently asked questions
What is FDA product code PYT?
PYT is the FDA product code for device, fertility diagnostic, contraceptive, software application. It is a Class II device, regulated under 21 CFR 884.5370 and reviewed by the Obstetrics and Gynecology panel.
What device class is PYT?
Class II, regulation 21 CFR 884.5370. Typical premarket route: 510(k).
How long does a 510(k) take for product code PYT?
Across 6 cleared submissions the average was 196 days from receipt to decision (median 176).
Which companies have the most PYT clearances?
Natural Cycles Nordic AB (5); Biowink GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PYT
- Run a recall and safety report across every PYT manufacturer
- Watch product code PYT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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