Cleared Traditional

CAUTION CONDOMS (K033163) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033163 · Richard Van Haussen America, Inc. · Obstetrics & Gynecology device
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Apr 2004
Decision
172d
Days
Class 2
Risk

K033163 is an FDA 510(k) clearance for the CAUTION CONDOMS. Classified as Condom With Nonoxynol-9 (product code LTZ), Class II - Special Controls.

Submitted by Richard Van Haussen America, Inc. (Los Angeles, US). The FDA issued a Cleared decision on April 27, 2004 after a review of 172 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5310 - 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 Richard Van Haussen America, Inc. devices

Submission Details

510(k) Number K033163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2003
Decision Date April 27, 2004
Days to Decision 172 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 160d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LTZ Condom With Nonoxynol-9
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5310
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.