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Kwikeze Male Condom Applicator

by Condax, LLC

510(k) K031007

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK031007 Date14 Nov 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HIS
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Kwikeze Male Condom Applicator is an elliptical polyethylene plastic ring designed to facilitate condom application. It is packaged in a collapsed state held by a polyurethane band with a condom positioned within inner folds. Upon removal of the band, the applicator expands to its original oval shape, stretching the attached condom to facilitate insertion and correct positioning on an erect penis.

This device is intended for consumer use in a home setting. It is a Class II medical device with FDA 510(k) clearance (K031007) and is regulated under product code HIS. The applicator is supplied in a collapsed state and is designed for single-use application of condoms.

Other devices from Condax, LLC

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Kwikeze Male Condom Applicator used for?

    The Kwikeze Male Condom Applicator is an elliptical polyethylene plastic ring designed to facilitate condom application. It stretches the attached condom to help with insertion and correct positioning on an erect penis.

  • How is the Kwikeze Male Condom Applicator supplied?

    The applicator is packaged in a collapsed state held by a polyurethane band with a condom positioned within inner folds. When the band is removed, the applicator expands to its original oval shape.

  • Is the Kwikeze Male Condom Applicator reusable?

    No, the Kwikeze Male Condom Applicator is designed for single-use application of condoms only. It should not be reused for hygiene and safety reasons.

  • What is the regulatory classification of the Kwikeze Male Condom Applicator?

    The Kwikeze Male Condom Applicator is a Class II medical device with FDA 510(k) clearance (K031007) and is regulated under product code HIS. It is intended for consumer use in a home setting.