Cleared Traditional

K021186 - CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG,

K021186 is an FDA 510(k) clearance for CONDOMI NATURE, manufactured by Condomi Erfert Prodoktionsgesellschaft Mbh. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K021186 · Condomi Erfert Prodoktionsgesellschaft Mbh · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
193d
Days
Class 2
Risk

K021186 is an FDA 510(k) clearance for the CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE,.... Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Condomi Erfert Prodoktionsgesellschaft Mbh (Great Neck, US). The FDA issued a Cleared decision on October 25, 2002 after a review of 193 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.

FDA 510(k) Submission Details - K021186

510(k) Number K021186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2002
Decision Date October 25, 2002
Days to Decision 193 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 161d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIS Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HIS Condom

All 399
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K021186.
UNDUS MALE LATEX CONDOM (WITH FLAVORING)
K023176 · Unidus Corp. · Dec 2002
UNIDUS MALE LATEX CONDOM
K023059 · Unidus Corp. · Dec 2002
SENSUA!
K021125 · Aac Consulting Group, Inc. · Oct 2002
MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM
K021875 · Pleasure Latex Products Sdn. Bhd. · Sep 2002
NATURAL AND COLORED LATEX CONDOM WITH FLAVORS
K020633 · Ls Rubber Sdn Bhd · May 2002
MALE LATEX CONDOM WITH RIBBED SURFACE
K020272 · Pleasure Latex Products Sdn. Bhd. · Apr 2002
K021186 · CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG,
Download PDF FDA Summary Condomi Erfert Prodok…