Cleared Traditional

OVUDATE (K844043) - FDA 510(k) Clearance

K844043 · Joel R.L. Ehren Kranz · Obstetrics & Gynecology device
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Feb 1985
Decision
121d
Days
-
Risk

K844043 is an FDA 510(k) clearance for the OVUDATE. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Joel R.L. Ehren Kranz (Morristown, US). The FDA issued a Cleared decision on February 15, 1985 after a review of 121 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 Joel R.L. Ehren Kranz devices

Submission Details

510(k) Number K844043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1984
Decision Date February 15, 1985
Days to Decision 121 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
39d faster than avg
Panel avg: 160d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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