Atlas FDA

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

Ameco Medical Industries — Predicate Candidate Screening

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

130 daysmedian FDA review time
274 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K152819Amecath Peripheral inserted Central Venous Catheter SetsAmeco Medical Industries2016-02-051300
K131144AMECO SHEATH INTRODUCERAmeco Medical Industries2013-08-151140
K131814AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETERAmeco Medical Industries2013-07-26360
K123943AMECATH DUAL LUMEN HEMODIALYSIS CATHETERAmeco Medical Industries2013-04-021030
K110794AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MAmeco Medical Industries2011-12-212740
K110793AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIAmeco Medical Industries2011-12-162690

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