Cleared Traditional

Durex Condom with Benzocaine (K211152) - FDA 510(k) Clearance

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

K211152 · Rb Health (Us), LLC · Obstetrics & Gynecology device
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May 2022
Decision
387d
Days
Class 2
Risk

K211152 is an FDA 510(k) clearance for the Durex Condom with Benzocaine. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Rb Health (Us), LLC (Parsippany, US). The FDA issued a Cleared decision on May 11, 2022 after a review of 387 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: Standard predicate-based submission. Elevated predicate reliance profile. 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.

View all Rb Health (Us), LLC devices

Submission Details

510(k) Number K211152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2021
Decision Date May 11, 2022
Days to Decision 387 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
227d slower than avg
Panel avg: 160d · This submission: 387d
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 Peers - HIS Condom

All 29
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K211152.
TROJAN Fire & Ice lubricated male natural rubber latex condom
K221906 · Church & Dwight Co., Inc. · Sep 2022
FAMA Male Latex Condoms
K220576 · Shanghai Personage Hygiene Products Co., Ltd. · Aug 2022
TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant
K221431 · Church & Dwight Co., Inc. · Jul 2022
Microthin Natural Rubber Latex Condom
K213921 · Suretex Limited · Apr 2022
Titan Condoms
K210208 · Titan Condoms, LLC · Feb 2022
Durex Patronus Wide
K213647 · Rb Health (Us), LLC · Feb 2022