Atlas FDA

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

Diagnostic Monitoring Software · Predicate Candidate Screening

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

32 daysmedian FDA review time
272 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K133014DMS 300-2W HOLTER ECG RECORDERDiagnostic Monitoring Software2014-05-192360
K062959DMS 300-2, 300-3 AND 300-4Diagnostic Monitoring Software2006-10-16170
K062088PREMIER 11 HOLTERDiagnostic Monitoring Software2006-08-25320
K062007DMS 300-7Diagnostic Monitoring Software2006-08-16300
K911615HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300Diagnostic Monitoring Software1992-01-082720

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