Cleared Abbreviated

Extremely Thin 003, ZERO ZERO THREE (K192669) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K192669 · Okamoto USA, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
303d
Days
Class 2
Risk

K192669 is an FDA 510(k) clearance for the Extremely Thin 003, ZERO ZERO THREE. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Okamoto USA, Inc. (Stratford, US). The FDA issued a Cleared decision on July 24, 2020 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Okamoto USA, Inc. devices

Submission Details

510(k) Number K192669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2019
Decision Date July 24, 2020
Days to Decision 303 days
Submission Type Abbreviated
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
143d slower than avg
Panel avg: 160d · This submission: 303d
Pathway characteristics
Standards-based clearance path.

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

Hyman, Phelps & McNamara, P.C.
Jeffrey N. Gibbs

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 29
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K192669.
Durex Penck Standard, Durex Penck XL
K200672 · Rb Health (Us), LLC · Nov 2020
Non-spermicidal Lubricated Male Latex Condom
K193578 · Global Protection Corp. · Aug 2020
CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed))
K201067 · Cupid Limited · Aug 2020
One Touch
K181844 · Thai Nippon Rubber Industry Public Company, Ltd. · Apr 2019
Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant
K180104 · Church & Dwight Co., Inc. · Mar 2018
One Touch Condom with Benzocaine
K171213 · Thai Nippon Rubber Industry Public Company Limited. · Jan 2018