Cleared Traditional

K823463 - RIGHT TIME RHYTHM CLOCK (FDA 510(k) Clearance)

K823463 · P.K. Morgan Instruments, Inc. · Obstetrics & Gynecology device
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Mar 1983
Decision
118d
Days
-
Risk

K823463 is an FDA 510(k) clearance for the RIGHT TIME RHYTHM CLOCK. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by P.K. Morgan Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1983 after a review of 118 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 P.K. Morgan Instruments, Inc. devices

Submission Details

510(k) Number K823463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1982
Decision Date March 17, 1983
Days to Decision 118 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
42d faster than avg
Panel avg: 160d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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