Atlas FDA

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

Roxwood Medical, Inc. · Predicate Candidate Screening

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

149 daysmedian FDA review time
224 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.2017-03-07260
K160681CenterCross Ultra CatheterRoxwood Medical, Inc.2016-06-17990
K152957MultiCross CatheterRoxwood Medical, Inc.2016-03-041490
K152456CenterCross Ultra CatheterRoxwood Medical, Inc.2016-01-261510
K151082MicroCross CatheterRoxwood Medical, Inc.2015-06-07460
K143744MicroCross CatheterRoxwood Medical, Inc.2015-04-141040
K140910CENTERCROSS CATHETERRoxwood Medical, Inc.2014-11-192240
K121763MULTICROSS SUPPORT CATHETERRoxwood Medical, Inc.2012-11-271650

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