510(k) · Cleared
ClearedClue Birth Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biowink GmbH · PYT Device, Fertility Diagnostic, Contraceptive, Software Application
Cleared on Feb 18, 2021 as substantially equivalent to DEN170052 (Natural Cycles Nordic AB, 2018) after a 444-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Feb 18, 2021
- Review
- 444 days
- Class
- Class II
- Product code
- PYT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170052 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backDEN170052 Natural CyclesNatural Cycles Nordic AB · 2018
- This deviceK193330 Clue Birth ControlBiowink GmbH · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170052 | Natural Cycles | Natural Cycles Nordic AB | 2018 | — |
| 0 (this device) | K193330 | Clue Birth Control | Biowink GmbH | 2021 | — |
Sources: FDA 510(k) 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN170052 | Natural CyclesSummary page 4…n Regulatory Class: II Product Code: PYT (Device, fertility diagnostic, contraceptive, software application) Predicate Device Natural Cycles Nordic AB, Natural Cycles (DEN170052) The predicate device has not been subject to a design-related recall. Device Description Clue Birth Control is a feature of t… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN170052.
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. 2021, 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?
Clue Birth Control is a software application for contraception for women ages 18 - 45 years old, to monitor their fertility and prevent pregnancy. Clue Birth Control is suitable for women with predictable 20 - 40 day cycles, who have not recently used hormonal birth control.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193330 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193330: Clue Birth Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193330
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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