510(k) · Cleared
ClearedOvusense
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fertility Focus, Ltd. · LHD Device, Fertility Diagnostic, Proceptive
Cleared on Aug 6, 2013 as substantially equivalent to K102499 (Cambridge Temperature Concepts, Ltd., 2011) and 1 other predicate after a 369-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Aug 6, 2013
- Review
- 369 days
- Class
- Class U
- Product code
- LHD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914085 (1991). 8 ancestors in all, the oldest K901512 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK914085 HMS-5000Vitalog Monitoring,Inc. · 1991
- 3 generations backK991045 Mini-Logger Series 2000Mini-Mitter Co., Inc. · 1999
- 2 generations backK033534 VitalsenseMini-Mitter Co., Inc. · 2004
- 1 generation backK102499 DuofertilityCambridge Temperature Concepts, Ltd. · 2011
- This deviceK122337 OvusenseFertility Focus, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914085 | HMS-5000 | Vitalog Monitoring,Inc. | 1991 | — |
| −3 | K991045 | Mini-Logger Series 2000 | Mini-Mitter Co., Inc. | 1999 | — |
| −2 | K033534 | Vitalsense | Mini-Mitter Co., Inc. | 2004 | — |
| −1 | K102499 | Duofertility | Cambridge Temperature Concepts, Ltd. | 2011 | — |
| 0 (this device) | K122337 | Ovusense | Fertility Focus, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
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.
Top candidate predicates for a new LHD device
- #1 K200163 Ava Fertility Trackerscore 0.7 · 1 generation · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K102499 | DuofertilitySummary page 1…Pre-amendment, Unclassified CLASSIFICATION Product Code: LHO AND PRODUCT CODE: PREDICATE DuoFertility Monitor, K102499 DEVICE NAME: Bioself 2000 Fertility Indicator, K90421 1 SUBSTANTIAL EQUIVALENCE: The Fertility Focus OvuSense Fer… | 2011 |
| * | K904211 | Bioself 2000 Fertility IndicatorSummary page 1…oduct Code: LHO AND PRODUCT CODE: PREDICATE DuoFertility Monitor, K102499 DEVICE NAME: Bioself 2000 Fertility Indicator, K90421 1 SUBSTANTIAL EQUIVALENCE: The Fertility Focus OvuSense Fertility Monitor is substantially equivalent to the legally marketed DuoF… | 1992 |
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?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All LHD devicesLHD Device, Fertility Diagnostic, Proceptive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Fertility Focus OvuSense Fertility Monitor (Fertility Focus OvuSense Fertility Monitor Starter Kit M009-US, which includes Reader M010-US and Personal Sensor M011) is intended for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122337: Ovusense.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122337
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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