Atlas FDA

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

Corinth Medtech, Inc. — Predicate Candidate Screening

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

52 daysmedian FDA review time
149 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K230205Veloxion SystemCorinth Medtech, Inc.2023-02-24300
K191341Veloxion Controller Kit, Veloxion Fluid Control Set, VeloxioCorinth Medtech, Inc.2019-06-13240
K191335Veloxion Controller Kit, Veloxion Fluid Control Set, VeloxioCorinth Medtech, Inc.2019-06-06200
K190113Veloxion Controller Kit, Veloxion Fluid Control Set, VeloxioCorinth Medtech, Inc.2019-04-24900
K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, VeloxioCorinth Medtech, Inc.2019-03-15520
K180752Veloxion System, Veloxion Controller Kit, Veloxion ResectingCorinth Medtech, Inc.2018-07-251250
K162979Veloxion SystemCorinth Medtech, Inc.2017-03-241490

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