510(k) · Cleared
ClearedClearplan 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 Oct 28, 1998 after a 209-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Oct 28, 1998
- Review
- 209 days
- Class
- Class I
- Product code
- NGE
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981207 | Clearplan Easy Fertility Monitor | Unipath, Ltd. | 1998 | — |
| +1 | K020808 | Fertilite OV | Pheromone Sciences Corp. | 2002 | — |
| +1 | K012252 | Quik-Check Ovulation Predictor | ACON Laboratories, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
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? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K020808 (Pheromone Sciences Corp., 2002) has gone furthest, with 0 descendants of its own.
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 is an interactive system which is designed to identify those days in a woman’s cycle on which intercourse is most likely to lead to conception. Women are instructed to act on this information to achieve a pregnancy. The target market for the CLEARPLAN EASY FERTILITY MONITOR is women who are either planning a pregnancy, or who have been trying for a pregnancy for a number of months without success. In addition, the…
Read the full statement (177 words)
The CLEARPLAN EASY FERTILITY MONITOR is an interactive system which is designed to identify those days in a woman’s cycle on which intercourse is most likely to lead to conception. Women are instructed to act on this information to achieve a pregnancy.
The target market for the CLEARPLAN EASY FERTILITY MONITOR is women who are either planning a pregnancy, or who have been trying for a pregnancy for a number of months without success. In addition, the device will be of use to Obstetricians, Gynaecologists and Fertility Specialists.
The device will provide warning of impending ovulation through detection of the luteinising hormone (LH) surge which precedes it. Besides this feature, CLEARPLAN EASY FERTILITY MONITOR will provide additional warning of ovulation through detection of a rise in the level of estrone-3-glucuronide (E3G) in urine. The product will define three phases of fertility through early morning urine hormone measurement: low, high and peak fertility.
CLEARPLAN EASY FERTILITY MONITOR is designed to adapt its testing strategy to the individual.
CLEARPLAN FERTILITY EASY MONITOR will be labelled not for contraceptive use.
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/K981207 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981207: Clearplan Easy Fertility Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981207
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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