Cleared Traditional

K160644 - Lelo Hex Natural Rubber Latex Condom

K160644 is an FDA 510(k) clearance for Lelo Hex Natural Rubber Latex Condom, manufactured by Lelo, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIS cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K160644 · Lelo, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
115d
Days
Class 2
Risk

K160644 is an FDA 510(k) clearance for the Lelo 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 June 30, 2016 after a review of 115 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. 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. Standard predicate reliance. 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 Lelo, Inc. devices

FDA 510(k) Submission Details - K160644

510(k) Number K160644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2016
Decision Date June 30, 2016
Days to Decision 115 days
Submission Type Traditional
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
46d faster than avg
Panel avg: 161d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K160644.
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
Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors)
K161195 · M3 Global Enterprises, LLC · Aug 2016
O-RING Condom
K150828 · O-Ring Products, LLC · Dec 2015
Banana Gold
K150857 · Hankook Latex Gongup Co., Ltd. · Aug 2015
TheyFit Male Condom
K150072 · Theyfit · Apr 2015