510(k) · Cleared
ClearedOvulon Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conception Technology, Inc. · NGE Test, Luteinizing Hormone (Lh), Over The Counter
Cleared on Jan 7, 1998 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 7, 1998
- Review
- 90 days
- Class
- Class I
- Product code
- NGE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NGE? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All NGE devicesNGE Test, Luteinizing Hormone (Lh), Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NGE
FDA has decided no NGE device since 2007.
Median 510(k) review, days · NGE
Too few NGE 510(k)s in any year since 2007 to give a median.
Recalls per year · NGE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGE
2in 2025
MAUDE reports naming product code NGE, 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 | — | 1 | 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 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 7 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ovulon Monitor is a fertility aid intended for over-the-counter purchase. It is an electronic biosensor designed for home use that yields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina. The Ovulon Monitor is intended for daily use in normally cycling (i.e., regularly menstruating and, presumably, ovulating) healthy females who may desire to achieve…
Read the full statement (194 words)
The Ovulon Monitor is a fertility aid intended for over-the-counter purchase. It is an electronic biosensor designed for home use that yields digital information (data points) relative to electron flow in the extracellular milieu of the posterior fornix and paracervical region of the vagina.
The Ovulon Monitor is intended for daily use in normally cycling (i.e., regularly menstruating and, presumably, ovulating) healthy females who may desire to achieve pregnancy (conception). Much as a basal body temperature thermometer or a home urine LH kit, the Ovulon Monitor serves as an independent information aid to the woman by helping to define the fertile window near the midpoint of each monthly cycle, whereby she may choose the proper timing for vaginal intercourse. If the user chooses the guidance of a physician for fertility treatment, the Ovulon Monitor may serve to provide the user and her physician with data to better time artificial insemination or other interventional techniques.
The Ovulon Monitor is to be used as an aid to conception and is not to be used for contraception.
After six (6) or more cycles, if the user is not successful in achieving conception, she should consult her physician.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973860: Ovulon Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973860
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026