Cleared Traditional

K033163 - CAUTION CONDOMS

K033163 is an FDA 510(k) clearance for CAUTION CONDOMS, manufactured by Richard Van Haussen America, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code LTZ cleared through the Traditional 510(k) pathway after a 172-day FDA review.

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

FDA 510(k) Submission Details - K033163

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.

LTZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LTZ Condom With Nonoxynol-9

All 16
Devices cleared under the same product code (LTZ) and FDA review panel - the closest regulatory comparables to K033163.
INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT)
K992438 · Indus Medicare , Ltd. · Aug 1999
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
K991047 · Hardcover Products, Inc. · Jun 1999
MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
K990669 · Dongkuk Techco Rubber Industries Sdn. Bhd. · May 1999
MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS
K981955 · Ls Rubber Sdn Bhd · Mar 1999
ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
K981621 · Suretex Prophylactics (India) , Ltd. · Jun 1998
LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT
K974324 · Reddy Medtech Health Products , Ltd. · Feb 1998