Cleared Traditional

K002726 - TCOYF FERTILITY SOFTWARE VERSION 1.0

K002726 · Ovusoft, LLC · Obstetrics & Gynecology device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Apr 2001

Decision

218d

Days

Risk

K002726 is an FDA 510(k) clearance for the TCOYF FERTILITY SOFTWARE VERSION 1.0. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Ovusoft, LLC (Hampton, US). The FDA issued a Cleared decision on April 6, 2001 after a review of 218 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K002726

510(k) Number	K002726 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 31, 2000
Decision Date	April 06, 2001
Days to Decision	218 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

57d slower than avg

Panel avg: 161d · This submission: 218d

Pathway characteristics

Predicate-based equivalence.

LHD Device Classification - Class 0,

Product Code	LHD Device, Fertility Diagnostic, Proceptive
Device Class	-

Regulatory Peers - LHD Device, Fertility Diagnostic, Proceptive

All 23

Devices cleared under the same product code (LHD) and FDA review panel - the closest regulatory comparables to K002726.

LADY COMP USA

K050094 · Lady Comp USA · Apr 2006

MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921

K030961 · Microlife Corp. · Sep 2003

PETIT SOPHIA

K021978 · Nishitomo Co., Inc. · Apr 2003

MEDI-AID BASAL THERMOMETER

K952756 · Polymedica Industries, Inc. · Sep 1995

B-D DIGITAL THERMOMETER

K945427 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1995

BIOSELF 2000 FERTILITY INDICATOR

K904211 · Bioself, Inc. · Oct 1992

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K002726

Ovusoft, LLC

Hampton, VA · US

GENE GRANT

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Obstetrics & Gynecology

View all devices by Ovusoft, LLC →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: April 6, 2001. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: October 2026.

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