Cleared Traditional

K851291 - LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/B...

K851291 is the FDA 510(k) clearance for LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/B... by Manexim Multicorp, Ltd.. It is a Class 2 Obstetrics & Gynecology device (product code HIS) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K851291 · Manexim Multicorp, Ltd. · Obstetrics & Gynecology device
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May 1985
Decision
51d
Days
Class 2
Risk

K851291 is an FDA 510(k) clearance for the LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Manexim Multicorp, Ltd. (Canada Law1v6, CA). The FDA issued a Cleared decision on May 22, 1985 after a review of 51 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Manexim Multicorp, Ltd. devices

Submission Details

510(k) Number K851291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date May 22, 1985
Days to Decision 51 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
109d faster than avg
Panel avg: 160d · This submission: 51d
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.