510(k) Report

510(k) · Cleared

Cleared

Fertilite OV

K020808510(k) TraditionalCleared Sep 23, 2002195-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

Pheromone Sciences Corp. · NGE Test, Luteinizing Hormone (Lh), Over The Counter

Cleared on Sep 23, 2002 as substantially equivalent to K981207 (Unipath, Ltd., 1998) and 2 other predicates after a 195-day review. Its family tree reaches back 1 generation to 1985.

Decided
Sep 23, 2002
Review
195 days
Class
Class I
Product code
NGE
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K850579 (1985). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1998: 1 other ancestorK850579 · Cue Fertility Monitor · Zetek, Inc. · 19851985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K850579 · Cue Fertility Monitor · Zetek, Inc. · 19850
  1. Root · 1 generation backK850579 Cue Fertility MonitorZetek, Inc. · 1985
  2. This deviceK020808 Fertilite OVPheromone Sciences Corp. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K850579Cue Fertility MonitorZetek, Inc.1985—
0 (this device)K020808Fertilite OVPheromone Sciences Corp.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
FIG. 1 — Lineage of K020808, 1985–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K981207Clearplan Easy Fertility Monitor
Summary page 1
…tor Classification Name: Device, Fertility, Diagnostic, Proceptive 111. Predicate Devices Clear Plan Easy Fertility Monitor (Unpath Ltd.) K981207 Cue Fertility Monitor (Zetec Inc.) K850579 Tycoyf Fertility Software (Ovusofl Inc.)…
Unipath, Ltd.1998—
*K850579Cue Fertility Monitor
Summary page 1
…eptive 111. Predicate Devices Clear Plan Easy Fertility Monitor (Unpath Ltd.) K981207 Cue Fertility Monitor (Zetec Inc.) K850579 Tycoyf Fertility Software (Ovusofl Inc.) KO02726 IV. Device Description The PSC Fertility Moni…
Zetek, Inc.1985—
*K002726Tcoyf Fertility Software Version 1.0Ovusoft, LLC2001—

Also cleared against K981207: 1 other device →

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.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • 1 other device also cites its predicate K981207.

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

2008: 12023: 72025: 1
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

2017: 12022: 12024: 12025: 2
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—10
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—01
20230—70
20240—01
20250—12
20260—0—

What is it indicated for?

Fertilitt OVT” (PSC Fertility Monitor) is an over-the-counter (“OTC”) in vitro diagnostic (“IVD”) device intended for use by women as an aid in conception by measuring hormone-induced changes in the composition of the perspiration on the skin during the menstrual cycle. Properly used, it gives more notice for conceiving and is not invasive. It is NOT to be used for contraception.

Indications for use as stated in the FDA summary.

Also cleared against K981207

1 other device cites the same predicate.

  • K012252Quik-Check Ovulation PredictorACON Laboratories, Inc. · 2001

Recent decisions in NGE

The NGE category page

  • K990223Modification of Clearplan Easy Fertility MonitorUnipath, Ltd. · 1999
  • K981207Clearplan Easy Fertility MonitorUnipath, Ltd. · 1998
  • K973860Ovulon MonitorConception Technology, Inc. · 1998
  • K863121Peak Ovulation PredictorMicron Technology, Inc. · 1986
  • K850579Cue Fertility MonitorZetek, Inc. · 1985

https://510kreport.com/device/K020808 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020808: Fertilite OV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020808

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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