Cleared Traditional

K050094 - LADY COMP USA

K050094 · Lady Comp USA · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
461d
Days
-
Risk

K050094 is an FDA 510(k) clearance for the LADY COMP USA. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Lady Comp USA (Jeffersonville, US). The FDA issued a Cleared decision on April 20, 2006 after a review of 461 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

FDA 510(k) Submission Details - K050094

510(k) Number K050094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2005
Decision Date April 20, 2006
Days to Decision 461 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
300d slower than avg
Panel avg: 161d · This submission: 461d
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 18
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TCOYF FERTILITY SOFTWARE VERSION 1.0
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K050094 · LADY COMP USA
Download PDF FDA Summary Lady Comp USA