Cleared Traditional

BIOSELF 101 (K823209) - FDA 510(k) Clearance

K823209 · Bioself, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1983
Decision
110d
Days
-
Risk

K823209 is an FDA 510(k) clearance for the BIOSELF 101. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Bioself, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 15, 1983 after a review of 110 days - within the typical 510(k) review window.

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.

View all Bioself, Inc. devices

Submission Details

510(k) Number K823209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1982
Decision Date February 15, 1983
Days to Decision 110 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
50d faster than avg
Panel avg: 160d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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