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

Barco NV Display Systems · Predicate Candidate Screening

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

49 daysmedian FDA review time
168 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K001753MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEMBarco NV Display Systems2000-07-27490
K001748MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEMBarco NV Display Systems2000-07-27490
K001750MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEMBarco NV Display Systems2000-07-21430
K001751MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEMBarco NV Display Systems2000-07-19410
K001752MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEMBarco NV Display Systems2000-07-19410
K001754MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEMBarco NV Display Systems2000-07-19410
K001747MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEMBarco NV Display Systems2000-07-13350
K982820BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEBarco NV Display Systems1998-10-08580
K980541BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAYBarco NV Display Systems1998-04-09570
K972701BARCO MWD 321 MEDICAL WORKSTATION DISPLAYBarco NV Display Systems1998-01-021680

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