Cleared Traditional

BIOSELF 2000 FERTILITY INDICATOR (K904211) - FDA 510(k) Clearance

K904211 · Bioself, Inc. · Obstetrics & Gynecology device
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Oct 1992
Decision
763d
Days
-
Risk

K904211 is an FDA 510(k) clearance for the BIOSELF 2000 FERTILITY INDICATOR. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Bioself, Inc. (Thonex-Geneve-Suisse, CH). The FDA issued a Cleared decision on October 14, 1992 after a review of 763 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.

View all Bioself, Inc. devices

Submission Details

510(k) Number K904211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1990
Decision Date October 14, 1992
Days to Decision 763 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
603d slower than avg
Panel avg: 160d · This submission: 763d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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