Atlas FDA

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

Meridian Medical Systems, LLC · Predicate Candidate Screening

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

264 daysmedian FDA review time
267 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K162687Paragon 2Meridian Medical Systems, LLC2016-10-21240
K143232Universal Digital Interface 2W, UDI 2WMeridian Medical Systems, LLC2015-01-30810
K140251UNIVERSAL DIGITAL INTERFACE 2, UDI 2Meridian Medical Systems, LLC2014-10-222640
K112527UNIVERSAL DIGITAL INTERFACE (UDI) 1717Meridian Medical Systems, LLC2012-05-222650
K111305UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417WMeridian Medical Systems, LLC2012-01-312670
K103599UNIVERSAL DIGITAL INTERFACE (UDI) 1717Meridian Medical Systems, LLC2011-04-271400

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