510(k) Report

Devices descending from K011253

14 later devices reach Flavored Male Latex Condom through their predicates, nearest generation first.

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