Atlas FDA

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

Global Instrumentation, LLC — Predicate Candidate Screening

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

214 daysmedian FDA review time
266 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252840M12 Telemetry SystemGlobal Instrumentation, LLC2026-05-292660
K202456M5 RecorderGlobal Instrumentation, LLC2020-12-291240
K162463Matrix Data Management SystemGlobal Instrumentation, LLC2017-05-242640
K152701Matrix Mini ECG MonitorGlobal Instrumentation, LLC2016-04-222140
K051730MATRIX HOLTER SYSTEM, MODEL M12Global Instrumentation, LLC2005-09-26910

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