Cleared Traditional

K021125 - SENSUA!

K021125 is an FDA 510(k) clearance for SENSUA!, manufactured by Aac Consulting Group, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K021125 · Aac Consulting Group, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
200d
Days
Class 2
Risk

K021125 is an FDA 510(k) clearance for the SENSUA!. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Aac Consulting Group, Inc. (Rockville, US). The FDA issued a Cleared decision on October 25, 2002 after a review of 200 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 - K021125

510(k) Number K021125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2002
Decision Date October 25, 2002
Days to Decision 200 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
39d slower than avg
Panel avg: 161d · This submission: 200d
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 381
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K021125.
UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING)
K023175 · Unidus Corp. · Dec 2002
UNDUS MALE LATEX CONDOM (WITH FLAVORING)
K023176 · Unidus Corp. · Dec 2002
UNIDUS MALE LATEX CONDOM
K023059 · Unidus Corp. · Dec 2002
CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE, CONDOMI XXL, CONDOMI STRONG,
K021186 · Condomi Erfert Prodoktionsgesellschaft Mbh · 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
K021125 · SENSUA!
Download PDF FDA Summary Aac Consulting Group,…