Cleared Traditional

K871358 - SENSATIONS BRAND CONDOMS

K871358 is the FDA 510(k) clearance for SENSATIONS BRAND CONDOMS by Apex Medical Technologies, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIS) cleared through the Traditional 510(k) pathway after a 695-day FDA review.

K871358 · Apex Medical Technologies, Inc. · Obstetrics & Gynecology device
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Mar 1989
Decision
695d
Days
Class 2
Risk

K871358 is an FDA 510(k) clearance for the SENSATIONS BRAND CONDOMS. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Apex Medical Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on March 1, 1989 after a review of 695 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Apex Medical Technologies, Inc. devices

Submission Details

510(k) Number K871358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1987
Decision Date March 01, 1989
Days to Decision 695 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
535d slower than avg
Panel avg: 160d · This submission: 695d
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.