Cleared Traditional

K860909 - WORLDS BEST AND WORLDS BEST EXTRA SERIE...

K860909 is the FDA 510(k) clearance for WORLDS BEST AND WORLDS BEST EXTRA SERIE... by U. C. Import & Co.. It is a Class 2 Obstetrics & Gynecology device (product code HIS) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K860909 · U. C. Import & Co. · Obstetrics & Gynecology device
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Aug 1986
Decision
162d
Days
Class 2
Risk

K860909 is an FDA 510(k) clearance for the WORLDS BEST AND WORLDS BEST EXTRA SERIES (CONDOMS). Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by U. C. Import & Co. (Beverly Hills, US). The FDA issued a Cleared decision on August 19, 1986 after a review of 162 days - an extended review 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: 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 U. C. Import & Co. devices

Submission Details

510(k) Number K860909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1986
Decision Date August 19, 1986
Days to Decision 162 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
2d slower than avg
Panel avg: 160d · This submission: 162d
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.