FDA 510(k) · Natural Cycles
K231274: Natural Cycles (Natural Cycles Nordic AB)
Natural Cycles Nordic AB received FDA 510(k) K231274 for Natural Cycles, with a decision date of Aug 24, 2023 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K231274 |
|---|---|
| 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 | May 2, 2023 |
| Decision date | Aug 24, 2023 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Natural Cycles is a stand-alone software application, intended for women 18 years and older, to monitor their fertility. Natural Cycles can be used for preventing a pregnancy (contraception) or planning a pregnancy (conception).
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
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.
- K202897 Natural Cycles (Natural Cycles)
Later records that cite K231274
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.