510(k) Report

Devices descending from K090819

13 later devices reach Ontex Tampon (Unscented) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190218Unscented Menstrual TamponQingdao Youjia Hygiene Technology Co., Ltd.20191—
+1K162746Ontex and other proprietary namesOntex Bvba20171—
+1K122603Ontex and Other Proprietary NamesOntex Bvba20128—
+2K223883Daye TamponAnnes Daye, Ltd.20230—
+2K192557Youjia Unscented Tampon with Plastic ApplicatorsQingdao Youjia Hygiene Technology Co., Ltd.20200—
+2K191666Unscented W long plastic and cardboard applicator tamponsOntex Bvba20190—
+2K142786Ontex Unscented Tampons with Colored Plastic ApplicatorsOntex Bvba20154—
+2K132595Ontex Roll Wadding Plastic Applicator Compact Size Unscented TamponsOntex Bvba20140—
+2K132208Ontex and Others Proprietary NamesOntex Bvba20140—
+3K232598Unscented Menstrual TamponUnibeauty (Hubei) Technology Co., Ltd.20233—
+4K252613Unscented menstrual three-piece applicator tamponUnibeauty (Hubei) Technology Co., Ltd.20250—
+4K251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator…Unibeauty (Hubei) Technology Co., Ltd.20251—
+5K253719Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator…Unibeauty (Hubei) Technology Co., Ltd.20250—