510(k) · Cleared
ClearedModification of Clearplan Easy Fertility Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unipath, Ltd. · NGE Test, Luteinizing Hormone (Lh), Over The Counter
Cleared on Feb 24, 1999 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 24, 1999
- Review
- 30 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 CLEARPLAN EASY FERTILITY MONITOR, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women as an aid to conception by identifying those days in a woman’s cydle on which intercourse is most likely to lead to conception via a urine test. The device consists of a software-controlled electronic monitor and packs of test sticks. The product will be made available to the consumer through pharmacies and drug stores. The…
Read the full statement (305 words)
The CLEARPLAN EASY FERTILITY MONITOR, an over-the-counter (OTC) in vitro diagnostic device, is intended to be used by women as an aid to conception by identifying those days in a woman’s cydle on which intercourse is most likely to lead to conception via a urine test. The device consists of a software-controlled electronic monitor and packs of test sticks. The product will be made available to the consumer through pharmacies and drug stores.
The CLEARPLAN DATA TRANSFER SYSTEM is an accessory to the CLEARPLAN EASY FERTILITY MONITOR which allows the information collected by this product to be transferred to and stored on a computer, and viewed on the computer display or printed. The CLEARPLAN DATA TRANSFER SYSTEM also allows the time of acts of intercourse to be recorded electronically and the data to be collated on the computer with the information collected by the CLEARPLAN EASY FERTILITY MONITOR.
The CLEARPLAN DATA TRANSFER SYSTEM consists of a software controlled electronic card reader, a personal computer software package, electronic memory cards and user instructions.
The target market for the CLEARPLAN DATA TRANSFER SYSTEM is women who have purchased the CLEARPLAN EASY FERTILITY MONITOR. In addition the device will be of use to Obstetricians, Gynaecologists and Fertility Specialists.
The CLEARPLAN DATA TRANSFER SYSTEM is intended to be used to transfer data which have already been collected by the the CLEARPLAN EASY FERTILITY MONITOR to a computer. The information which is presented to the user of the device is limited to that which the they could have recorded on paper on a daily basis by noting the indications given by the CLEARPLAN EASY FERTILITY MONITOR and the user’s own activities. Therefore the CLEARPLAN DATA TRANSFER SYSTEM does not affect the intended use of the CLEARPLAN EASY FERTILITY MONITOR or the fundamental scientific technology of the CLEARPLAN EASY FERTILITY MONITOR.
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/K990223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990223: Modification of Clearplan Easy Fertility Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990223
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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