510(k) Report

Devices descending from K081413

6 later devices reach Twinlotus and Shields Natural Rubber Latex Condom through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103119Billy Boy Male Latex CondomSheila Pickering PHD20115—
+2K120287Trojan Magnum Condom with Fire & Ice LubricantChurch & Dwight Co., Inc.20120—
+2K120394Lifestyles Zero Lubricated Latex CondomAnsell Heathcare Products, LLC201211
+2K111093Billy Boy Male Latex CondomMapa GmbH20111—
+3K153016aoni Natural Rubber Latex CondomGuangzhou Daming United Rubber Products, Ltd.20160—
+3K141256Okamoto Studded CondomOkamoto USA, Inc.20140—