Cleared Traditional

K203541 - Okamoto 002 Lubricated Polyurethane Male Condom (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203541 · Okamoto USA, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Feb 2022
Decision
449d
Days
Class 2
Risk

K203541 is an FDA 510(k) clearance for the Okamoto 002 Lubricated Polyurethane Male Condom. Classified as Condom, Synthetic (product code MOL), Class II - Special Controls.

Submitted by Okamoto USA, Inc. (Stratford, US). The FDA issued a Cleared decision on February 25, 2022 after a review of 449 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Okamoto USA, Inc. devices

Submission Details

510(k) Number K203541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2020
Decision Date February 25, 2022
Days to Decision 449 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
289d slower than avg
Panel avg: 160d · This submission: 449d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MOL Condom, Synthetic
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.
Jeff 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 - MOL Condom, Synthetic

All 21
Devices cleared under the same product code (MOL) and FDA review panel - the closest regulatory comparables to K203541.
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