Cleared Traditional

K854622 - PROPHYLACTIC (CONDOM)

K854622 is the FDA 510(k) clearance for PROPHYLACTIC (CONDOM) by Medelec Intl. Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HIS) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K854622 · Medelec Intl. Corp. · Obstetrics & Gynecology device
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Apr 1986
Decision
144d
Days
Class 2
Risk

K854622 is an FDA 510(k) clearance for the PROPHYLACTIC (CONDOM). Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Medelec Intl. Corp. (Miami Beach, US). The FDA issued a Cleared decision on April 11, 1986 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. 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 Medelec Intl. Corp. devices

Submission Details

510(k) Number K854622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date April 11, 1986
Days to Decision 144 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
16d faster than avg
Panel avg: 160d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.