FDA De Novo · Natural Cycles
DEN170052: Natural Cycles (Natural Cycles Nordic AB)
Natural Cycles Nordic AB received FDA De Novo DEN170052 for Natural Cycles, with a decision date of Aug 10, 2018.
Prescription or OTC: OTC parsed from FDA documents (derived: De Novo review text mentions OTC only)
FDA facts
| FDA number | DEN170052 |
|---|---|
| Pathway | De Novo |
| 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 | Sep 20, 2017 |
| Decision date | Aug 10, 2018 |
| Decision | Unknown (DENG) |
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 decision 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
A De Novo request is for a new type of device with no legally marketed predicate. When FDA grants it, the device can serve as a predicate for later 510(k) submissions. 2 records in this database cite DEN170052 as a predicate (listed below).
Later records that cite DEN170052
ChatPPG interpretation
A granted De Novo request authorizes a new type of low- to moderate-risk device and creates a classification regulation for it (here 21 CFR 884.5370). The usual wording is "granted" or "authorized", not "approved". 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.