Cleared Traditional

TCOYF FERTILITY SOFTWARE VERSION 1.0 (K002726) - FDA 510(k) Clearance

K002726 · Ovusoft, LLC · Obstetrics & Gynecology device
Download Printable Device Report (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.

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Submission Details

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
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 160d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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