Atlas FDA

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

Dart Medical Equipment · Predicate Candidate Screening

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

23 daysmedian FDA review time
33 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K820986EKG MONITORS, VARIOUS MODELSDart Medical Equipment1982-04-29230
K820904EKG TELEPHONE CONVERTERDart Medical Equipment1982-04-21210
K820828SAMMDart Medical Equipment1982-04-14190
K803315CRITERION II RHYTHM PROFILE MONITORDart Medical Equipment1981-01-22230
K802782THE CRITERION II PACING SYS. MONITORDart Medical Equipment1980-11-19160
K802325CRITERION II PACING SYSTEM MONITORSDart Medical Equipment1980-10-23300
K800286CRITERION II PACING SYSTEM MONITORSDart Medical Equipment1980-03-12330

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