510(k) · Cleared
ClearedAva Fertility Tracker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ava AG · LHD Device, Fertility Diagnostic, Proceptive
Cleared on Jan 19, 2021 as substantially equivalent to K050094 (Lady Comp USA, 2006) after a 363-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Jan 19, 2021
- Review
- 363 days
- Class
- Class U
- Product code
- LHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050094 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK050094 Lady Comp UsaLady Comp USA · 2006
- This deviceK200163 Ava Fertility TrackerAva AG · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050094 | Lady Comp Usa | Lady Comp USA | 2006 | — |
| 0 (this device) | K200163 | Ava Fertility Tracker | Ava AG | 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 LHD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K050094 | Lady Comp UsaSummary page 4…eptive Fertility Tracker Device Unclassified Classification Product Code LHD (Device, Fertility Diagnostic, Proceptive) Predicate Lady-Comp® USA (K050094) Device The predicate device has not been subject to a design-related recall. Device The Ava Fertilit… | 2006 |
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 K050094.
How does its category compare?
All LHD devicesLHD Device, Fertility Diagnostic, Proceptive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LHD
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LHD
Too few LHD 510(k)s in any year since 2007 to give a median.
Recalls per year · LHD
No recall names LHD since 2007.
Adverse event reports per year · LHD
1in 2023
MAUDE reports naming product code LHD, 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 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ava Fertility Tracker is intended to measure and display physiological parameters (body temperature, resting pulse rate, heart rate variability, and breathing rate) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200163 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200163: Ava Fertility Tracker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200163
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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