Cleared Traditional

BIOSELF TM 110 (K843699) - FDA 510(k) Clearance

K843699 · Bioself, Inc. · Obstetrics & Gynecology device
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Dec 1984
Decision
75d
Days
-
Risk

K843699 is an FDA 510(k) clearance for the BIOSELF TM 110. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Bioself, Inc. (Saint-Lambert, Que. Canad, US). The FDA issued a Cleared decision on December 4, 1984 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bioself, Inc. devices

Submission Details

510(k) Number K843699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1984
Decision Date December 04, 1984
Days to Decision 75 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
85d faster than avg
Panel avg: 160d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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