Cleared Traditional

FERTILITY FORECASTER COMPUTER PROGRAM (K880618) - FDA 510(k) Clearance

K880618 · Fertile Time, Ltd. · Obstetrics & Gynecology device
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Jun 1988
Decision
129d
Days
-
Risk

K880618 is an FDA 510(k) clearance for the FERTILITY FORECASTER COMPUTER PROGRAM. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Fertile Time, Ltd. (Dix Hills, US). The FDA issued a Cleared decision on June 24, 1988 after a review of 129 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 Fertile Time, Ltd. devices

Submission Details

510(k) Number K880618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1988
Decision Date June 24, 1988
Days to Decision 129 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
31d faster than avg
Panel avg: 160d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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