Cleared Traditional

K221431 - TROJAN(TM) Her Pleasure Warming male na...

K221431 is the FDA 510(k) clearance for TROJAN(TM) Her Pleasure Warming male na... by Church & Dwight Co., Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIS) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K221431 · Church & Dwight Co., Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
58d
Days
Class 2
Risk

K221431 is an FDA 510(k) clearance for the TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming.... Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on July 14, 2022 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Church & Dwight Co., Inc. devices

Submission Details

510(k) Number K221431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2022
Decision Date July 14, 2022
Days to Decision 58 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
102d faster than avg
Panel avg: 160d · This submission: 58d
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.

Regulatory Consultant

Full Circle Regulatory Consulting, LLC
Dawn Reilly-O'Dell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIS Condom

All 36
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