Cleared Special

K162511 - LELO RESPECT HEX Natural Rubber Latex Condom

K162511 is an FDA 510(k) clearance for LELO RESPECT HEX Natural Rubber Latex C..., manufactured by Lelo, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Special 510(k) pathway after a 127-day FDA review.

K162511 · Lelo, Inc. · Obstetrics & Gynecology device
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Jan 2017
Decision
127d
Days
Class 2
Risk

K162511 is an FDA 510(k) clearance for the LELO RESPECT HEX Natural Rubber Latex Condom. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Lelo, Inc. (San Jose, US). The FDA issued a Cleared decision on January 13, 2017 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lelo, Inc. devices

FDA 510(k) Submission Details - K162511

510(k) Number K162511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2016
Decision Date January 13, 2017
Days to Decision 127 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 161d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Regulatory Insight, Inc.
KEVIN WALLS

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 254
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K162511.
JUD custom fit condom
K172414 · Global Mailer Partners, LLC · Oct 2017
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K162919 · Zhejiang Xiangban Latex Products Co., Ltd. · Mar 2017
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K163107 · Ansell Healthcare Products, LLC · Jan 2017
aoni Natural Rubber Latex Condom
K153016 · Guangzhou Daming United Rubber Products , Ltd. · Oct 2016
Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
K161915 · Church & Dwight Co., Inc. · Sep 2016
Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant
K161545 · Church & Dwight Co., Inc. · Aug 2016