Atlas FDA

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

Miami Device Solutions, LLC — Predicate Candidate Screening

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

98 daysmedian FDA review time
151 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K182810Distal Radius Plating SystemMiami Device Solutions, LLC2018-12-10680
K172786MDS Plating SystemMiami Device Solutions, LLC2017-12-08840
K162898Olecranon Plating SystemMiami Device Solutions, LLC2017-03-171510
K162635Distal Radius Plating SystemMiami Device Solutions, LLC2016-10-21300
K161292Distal Radius Plating SystemMiami Device Solutions, LLC2016-08-15980
K161058Cannulated ScrewMiami Device Solutions, LLC2016-07-291050

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