510(k) Report

510(k) · Cleared

Cleared

Fertell Female Fertility Test

K032002510(k) TraditionalCleared Oct 30, 2003125-day reviewClass I21 CFR 862.1300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Genosis, Inc. · NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter

Cleared on Oct 30, 2003 as substantially equivalent to K002450 (Genua 1944, Inc., 2001) and 3 other predicates after a 125-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.

Decided
Oct 30, 2003
Review
125 days
Class
Class I
Product code
NGA
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K862813 (1986). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor2007: 1 descendant clearedK862813 · FSH Maiaclone Immunoradiometric Assay Kit · Serono Diagnostics, Inc. · 19861990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant K862813 · FSH Maiaclone Immunoradiometric Assay Kit · Serono Diagnostics, Inc. · 19860
  1. Root · 1 generation backK862813 FSH Maiaclone Immunoradiometric Assay KitSerono Diagnostics, Inc. · 1986
  2. This deviceK032002 Fertell Female Fertility TestGenosis, Inc. · 2003
  3. 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

GenerationNumberDeviceApplicantDecidedRecalls
−1K862813FSH Maiaclone Immunoradiometric Assay KitSerono Diagnostics, Inc.1986—
0 (this device)K032002Fertell Female Fertility TestGenosis, Inc.2003—
+1K070484Quantrx Female Fertility TestQuantrx Biomedical Corporation2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K032002, 1986–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 NGA? 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
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What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK023408Instacheck Menopause Predictor 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
…Counter) 21 C.F.R. 5 862.1300 Legally Marketed Predicate Devices: Instacheck Menopause Predictor Test (K023408) Surestep FSH Menopause Test (K010556) Genua Menopause Monitor Test Kit (K002450) AxSYM Follicle Stimulating Hormone (K935612)…
Kept off the family treeK010556Surestep 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
…21 C.F.R. 5 862.1300 Legally Marketed Predicate Devices: Instacheck Menopause Predictor Test (K023408) Surestep FSH Menopause Test (K010556) Genua Menopause Monitor Test Kit (K002450) AxSYM Follicle Stimulating Hormone (K935612) MAIAcloneTMFSH Assay (K8628 13) FIRS…
*K002450Genua Menopause Monitor Test Kit
Summary page 1
…862.1300 Legally Marketed Predicate Devices: Instacheck Menopause Predictor Test (K023408) Surestep FSH Menopause Test (K010556) Genua Menopause Monitor Test Kit (K002450) AxSYM Follicle Stimulating Hormone (K935612) MAIAcloneTMFSH Assay (K8628 13) FIRST RESPONSE Ovulation Predictor Test (K95358…
Genua 1944, Inc.2001—
*K935612Axsym Follicle Stimulating Hormone (FSH)
Summary page 1
…Instacheck Menopause Predictor Test (K023408) Surestep FSH Menopause Test (K010556) Genua Menopause Monitor Test Kit (K002450) AxSYM Follicle Stimulating Hormone (K935612) MAIAcloneTMFSH Assay (K8628 13) FIRST RESPONSE Ovulation Predictor Test (K95358 1)…
Abbott Laboratories19941
*K862813FSH Maiaclone Immunoradiometric Assay Kit
Summary page 1
…or Test (K023408) Surestep FSH Menopause Test (K010556) Genua Menopause Monitor Test Kit (K002450) AxSYM Follicle Stimulating Hormone (K935612) MAIAcloneTMFSH Assay (K8628 13) FIRST RESPONSE Ovulation Predictor Test (K95358 1)…
Serono Diagnostics, Inc.1986—
*K953581First Response Ovulation Predictor Test
Summary page 1
…556) Genua Menopause Monitor Test Kit (K002450) AxSYM Follicle Stimulating Hormone (K935612) MAIAcloneTMFSH Assay (K8628 13) FIRST RESPONSE Ovulation Predictor Test (K95358 1) 0020 Device Descript…
Armkel, LLC1995—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070484Quantrx Female Fertility TestQuantrx Biomedical Corporation20070

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?

  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K070484 (Quantrx Biomedical Corporation, 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NGA devices

NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NGA

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NGA

Too few NGA 510(k)s in any year since 2007 to give a median.

Recalls per year · NGA

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NGA

No MAUDE report names NGA since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—10
20260—0—

What is it indicated for?

The Fertell Female Fertility Test is intended to measure Follicle Stimulating Hormone (“FSH’) in urine as an adjunctive screen of fertility for home use by women who are attempting to conceive but have been unsuccessful.

Indications for use as stated in the FDA summary.

Recent decisions in NGA

The NGA category page

  • K070484Quantrx Female Fertility TestQuantrx Biomedical Corporation · 2007

https://510kreport.com/device/K032002 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032002: Fertell Female Fertility Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032002

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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