Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Ontex Bvba — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

247 daysmedian FDA review time
270 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K191666Unscented W long plastic and cardboard applicator tamponsOntex Bvba2019-12-201820
K162746Ontex and other proprietary namesOntex Bvba2017-03-031540
K142786Ontex Unscented Tampons with Colored Plastic ApplicatorsOntex Bvba2015-06-232700
K132595ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTEDOntex Bvba2014-04-232470
K132208ONTEX AND OTHERS PROPRIETARY NAMESOntex Bvba2014-04-102680
K122603ONTEX AND OTHER PROPRIETARY NAMESOntex Bvba2012-12-191140

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda