FDA applicant
Barco N.V.
FDA records 63 decisions for Barco N.V. (Kortrijk, BE) from 1998 to 2026: 63 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and PGY (Display, Diagnostic Radiology). Since 2016 its 510(k)s took a median of 35 days from receipt to decision, against 59 for FDA’s reviews in the same codes and years. Its devices cite 37 predicates, 26 of them its own earlier devices. 4 recalls are linked to its devices.
FDA’s records also spell it “Barco”, “Barco NV”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Barco N.V.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Barco N.V.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Barco”
FDA records each applicant name separately; these may or may not be the same firm.