510(k) Report

Devices descending from K980964

16 later devices reach Maxima, Trustex, Ria and Premium Condoms through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020633Natural and Colored Latex Condom with FlavorsLs Rubber Sdn Bhd200215—
+2K032227Durex Flavored Latex CondomSsl Americas, Inc.20047—
+2K023175Unidus Male Latex Condom (with Color and Flavoring)Unidus Corp.20026—
+3K081413Twinlotus and Shields Natural Rubber Latex CondomDailian Latex Company, Ltd.20086—
+3K041837Innolatex Male Latex Condoms Colored and ScentedInnolatex Sdn. Bhd20045—
+4K103119Billy Boy Male Latex CondomSheila Pickering PHD20115—
+4K070830Male Natural Rubber Latex Condom (with Coloring and Flavoring)Karex Industries Sdn. Bhd.20074—
+5K120287Trojan Magnum Condom with Fire & Ice LubricantChurch & Dwight Co., Inc.20120—
+5K120394Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC201211
+5K111093Billy Boy Male Latex CondomMapa GmbH20111—
+5K081886Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non…Karex Industries Sdn. Bhd.20093—
+6K153016aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd.20160—
+6K141256Okamoto Studded CondomOkamoto USA, Inc.20140—
+6K122219Theyfit Male CondomTheyfit20132—
+7K210208Titan CondomsTitan Condoms, LLC20220—
+7K150072TheyFit Male CondomTheyfit20150—