510(k) · Cleared

Cleared

Cue Fertility Monitor

K850579510(k) TraditionalCleared Mar 22, 198537-day reviewClass I21 CFR 862.1485

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

Zetek, Inc. · NGE Test, Luteinizing Hormone (Lh), Over The Counter

Cleared on Mar 22, 1985 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Mar 22, 1985
Review: 37 days
Class: Class I
Product code: NGE
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK850579 Cue Fertility MonitorZetek, Inc. · 1985
Descendant · cites it directly · 0 of its ownK020808 Fertilite OVPheromone Sciences Corp. · 2002

Most influential descendants

Showing 1 of 1 · See all

K020808Fertilite OVPheromone Sciences Corp. · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K850579	Cue Fertility Monitor	Zetek, Inc.	1985	—
+1	K020808	Fertilite OV	Pheromone Sciences Corp.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K850579, 1985–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K020808	Fertilite OV	Pheromone Sciences Corp.	2002	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, K020808 (Pheromone Sciences Corp., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NGE devices

NGE 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

2007high 7 (2023) · low 0 (2007)2026

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

Adverse event reports per year · NGE

2in 2025

2007high 2 (2025) · low 0 (2007)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	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	1	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	1
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	1
2023	—	7	0
2024	—	0	1
2025	—	1	2
2026	—	0	—

https://510kreport.com/device/K850579 · printed Nov 6, 2026

Cite this page

510(k) Report. “K850579: Cue 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/K850579

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026