Atlas FDA

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

PNE · Predicate Candidate Screening

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

241 daysmedian FDA review time
338 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250305Reprocessed Agilis NxT Steerable IntroducerInnovative Health2026-01-073380
K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntrSurgical Instrument Service and Savings, Inc.2025-12-193180
K232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFleInnovative Health, LLC2024-04-042690
K230376Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC2023-08-071750
K212165Reprocessed Carto Vizigo Bi-Directional Guiding SheathInnovative Health, LLC2022-03-102410
K170311Reprocessed Agilis NxT Steerable IntroducerInnovative Health, LLC2017-06-021210
K152090Reprocessed Steerable IntroducerSterilmed, Inc.2016-03-232402

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