Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

PCU · Predicate Candidate Screening

11 FDA 510(k) clearances under this product code; the 50 most recent screened below.

140 daysmedian FDA review time
252 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252648Niti-S SPAXUS StentTaewoong Medical Co., Ltd.2026-03-132040
K220112AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific Corporation2022-09-072370
K203132AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation2021-04-151780
K192043AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation2019-08-26260
K181905AXIOS Stent and Delivery System, AXIOS Stent and ElectrocautBoston Scientific Corporation2019-03-252522
K163272AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation2017-02-18890
K153088AXIOS Stent with Delivery System, AXIOS Stent with Electro-cBoston Scientific Corporation2015-12-11460
K152572AXIOS Stent and Delivery SystemBoston Scientific Corporation2015-10-06270
K150692AXIOS Stent with Electrocautery Enhanced Delivery SystemBoston Scientific Corp2015-08-051400
K140561AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIXlumena, Inc.2014-04-23490
DEN130007AXIOS STENT AND DELIVERY SYSTEMXlumena, Inc.2013-12-183020

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