Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Xoft, Inc. — Predicate Candidate Screening

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

161 daysmedian FDA review time
265 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K090914AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2Xoft, Inc.2009-07-161060
K090417AXXENT FLEXISHIELD MINIXoft, Inc.2009-06-231251
K083734AXXENT SURFACE APPLICATOR, MODEL 710257Xoft, Inc.2009-02-11570
K072616AXXENT VAGINAL APPLICATORXoft, Inc.2008-05-092350
K072683AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXoft, Inc.2008-02-291610
K050843AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXoft, Inc.2005-12-222650

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