510(k) · Cleared
ClearedFSH Menopause Predictor Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · CGJ Radioimmunoassay, Follicle-Stimulating Hormone
Cleared on Jun 17, 2004 after a 44-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Jun 17, 2004
- Review
- 44 days
- Class
- Class I
- Product code
- CGJ
- Recalls
- None
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK041165 FSH Menopause Predictor TestACON Laboratories, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK070484 Quantrx Female Fertility TestQuantrx Biomedical Corporation · 2007
Most influential descendants
Showing 1 of 1 · See all- K070484Quantrx Female Fertility TestQuantrx Biomedical Corporation · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041165 | FSH Menopause Predictor Test | ACON Laboratories, Inc. | 2004 | — |
| +1 | K070484 | Quantrx Female Fertility Test | Quantrx Biomedical Corporation | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 CGJ? 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K023408 | InstaCheck® FSH Menopause Test Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…verly, MA 01963 Substantially Equivalent Devices: Product: InstaCheck® FSH Menopause Test Manufactured by: Applied Biotech, Inc. 510(k) Number: K023408 PRODUCT DESCRIPTION: The FSH Menopause Predictor Test is a midstream test used for the qualitative measurement of FSH and t… |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070484 | Quantrx Female Fertility Test | 2007 | 0 |
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, K070484 (Quantrx Biomedical Corporation, 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CGJ devicesCGJ Radioimmunoassay, Follicle-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGJ
FDA has decided no CGJ device since 2007.
Median 510(k) review, days · CGJ
Too few CGJ 510(k)s in any year since 2007 to give a median.
Recalls per year · CGJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGJ
4in 2025
MAUDE reports naming product code CGJ, 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 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 1 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 1 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 1 | 3 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
FSH Menopause Predictor Test is a qualitative, one-step, midstream assay for the
detection of Follicle Stimulate Hormone (FSH) in urine to be used as an aid in predicting
menopause. The FSH Menopause Predictor Test is intended for over-the-counter use by
the lay consumer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041165 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041165: FSH Menopause Predictor Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041165
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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