De Novo · Granted
GrantedNatural Cycles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Natural Cycles Nordic AB · PYT Device, Fertility Diagnostic, Contraceptive, Software Application
Granted on Aug 10, 2018 as a new device type through De Novo after a 324-day review. 6 later devices descend from it.
- Decided
- Aug 10, 2018
- Review
- 324 days
- Class
- Class II
- Product code
- PYT
- Recalls
- None
6 later devices descend from it, 2 citing it directly.
- This deviceDEN170052 Natural CyclesNatural Cycles Nordic AB · 2018
- Descendant · cites it directly · 4 of its ownK202897 Natural CyclesNatural Cycles Nordic AB · 2021
- Descendant · 2 generations on · 3 of its ownK231274 Natural CyclesNatural Cycles Nordic AB · 2023
- Descendant · 3 generations on · 0 of its ownK253694 Natural CyclesNatural Cycles Nordic AB · 2026
- Descendant · 3 generations on · 0 of its ownK250561 Natural CyclesNatural Cycles Nordic AB · 2025
- Descendant · 3 generations on · 0 of its ownK241006 Natural CyclesNatural Cycles Nordic AB · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K202897Natural CyclesNatural Cycles Nordic AB · 2021 · cites it directly4descendants
- K231274Natural CyclesNatural Cycles Nordic AB · 2023 · 2 generations on3descendants
- K253694Natural CyclesNatural Cycles Nordic AB · 2026 · 3 generations on0descendants
- K250561Natural CyclesNatural Cycles Nordic AB · 2025 · 3 generations on0descendants
- K241006Natural CyclesNatural Cycles Nordic AB · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170052 | Natural Cycles | Natural Cycles Nordic AB | 2018 | — |
| +1 | K202897 | Natural Cycles | Natural Cycles Nordic AB | 2021 | — |
| +2 | K231274 | Natural Cycles | Natural Cycles Nordic AB | 2023 | — |
| +3 | K253694 | Natural Cycles | Natural Cycles Nordic AB | 2026 | — |
| +3 | K250561 | Natural Cycles | Natural Cycles Nordic AB | 2025 | — |
| +3 | K241006 | Natural Cycles | Natural Cycles Nordic AB | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PYT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PYT device
- #1 K231274 Natural Cyclesscore 15.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K202897 (Natural Cycles Nordic AB, 2021) has gone furthest, with 4 descendants of its own.
How does its category compare?
All PYT devicesPYT Device, Fertility Diagnostic, Contraceptive, Software Application: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PYT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PYT
Too few PYT 510(k)s in any year since 2007 to give a median.
Recalls per year · PYT
No recall names PYT since 2007.
Adverse event reports per year · PYT
2in 2023
MAUDE reports naming product code PYT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170052 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170052: Natural Cycles.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170052
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026