FDA 510(k) · Natural Cycles
K250561: Natural Cycles (Natural Cycles Nordic AB)
Natural Cycles Nordic AB received FDA 510(k) K250561 for Natural Cycles, with a decision date of Mar 21, 2025 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K250561 |
|---|---|
| Pathway | 510(k) |
| Applicant | Natural Cycles Nordic AB |
| Device name | Natural Cycles |
| Product code | PYT: Device, Fertility Diagnostic, Contraceptive, Software Application |
| Regulation (21 CFR) | 884.5370 |
| Device class | Class 2 |
| Date received | Feb 25, 2025 |
| Decision date | Mar 21, 2025 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
We could not extract the indications for this record. Check the FDA record for its summary or statement.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K231274 Natural Cycles (Natural Cycles)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code PYT is "Device, Fertility Diagnostic, Contraceptive, Software Application", class 2, 21 CFR 884.5370. FDA's definition: "Designed to monitor and provide fertility information to prevent pregnancy (contraception)."
Our labels for filtering: claim Fertility / cycle, sensor Other. These are heuristics, not FDA fields.