Cleared Traditional

GENDER CHOICE INFORMATION KIT, FEMALE AND MALE (K870999) - FDA 510(k) Clearance

K870999 · Procare C/O Wiley, Rein & Fielding · Obstetrics & Gynecology device
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Jul 1987
Decision
125d
Days
-
Risk

K870999 is an FDA 510(k) clearance for the GENDER CHOICE INFORMATION KIT, FEMALE AND MALE. Classified as Device, Fertility Diagnostic, Proceptive (product code LHD).

Submitted by Procare C/O Wiley, Rein & Fielding (Washington, US). The FDA issued a Cleared decision on July 14, 1987 after a review of 125 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.

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Submission Details

510(k) Number K870999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1987
Decision Date July 14, 1987
Days to Decision 125 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
35d faster than avg
Panel avg: 160d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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