Barco N.V.: FDA filings under this applicant name
FDA lists 60 510(k) clearances under the applicant name “Barco N.V.” (first 1998, latest 2024), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 68 days. Since 2017 the median was 57 days, against 111 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 35 |
| 2013 | 4 | 24 |
| 2014 | 5 | 92 |
| 2015 | 1 | 43 |
| 2016 | 1 | 16 |
| 2017 | 6 | 48 |
| 2018 | 1 | 115 |
| 2019 | 2 | 65 |
| 2020 | 1 | 26 |
| 2021 | 2 | 208 |
| 2022 | 1 | 84 |
| 2023 | 2 | 23 |
| 2024 | 2 | 38 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Barco N.V. took a median 57 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 37 | 37 |
| PGY | Display, Diagnostic Radiology | 12 | 12 |
| DXJ | Display, Cathode-Ray Tube, Medical | 5 | 5 |
| PSN | Light Based Imaging | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| PSY | Whole Slide Imaging System | 1 | 1 |
| PZZ | Digital Pathology Display | 1 | 1 |
Review panels
- Radiology (49)
- Cardiovascular (5)
- General and Plastic Surgery (4)
- Pathology (2)
Most recent Barco N.V. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243307 | LCD Monitor (MDEC-2523) | GCJ | 2024-12-13 | 53 |
| K242008 | Coronis OneLook | PGY | 2024-08-02 | 23 |
| K233693 | Nio Color 8MP (MDNC-8132) | PGY | 2023-12-11 | 24 |
| K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) | PGY | 2023-03-21 | 22 |
| K213957 | Demetra Dermatoscope BDEM-01 | PSN | 2022-03-11 | 84 |
| K203364 | MDPC-8127 | PSY | 2021-04-15 | 150 |
| K201408 | Demetra Analytics Toolkit | PSN | 2021-02-18 | 266 |
| K203106 | Nio Fusion 12MP (MDNC-12130) | PGY | 2020-11-10 | 26 |
| K192829 | Demetra BDEM-01 Dermatoscope | PSN | 2019-12-13 | 72 |
| K191845 | Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) | PGY | 2019-09-06 | 58 |
50 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 5 recall events; 3 initiated in the last five years. Most recent: 2025-05-09.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Barco NV Barcoview (14 510(k)s)
- Barco NV Display Systems (10 510(k)s)
- Barco (1 510(k)s)
- Barco Tekstil Sanayi VE Ticaret A.S. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Barco N.V.?
FDA lists 60 510(k) clearances under the applicant name “Barco N.V.” (first 1998, latest 2024), across 7 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Barco N.V.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Barco N.V. is 68 days. Since 2017: 57 days, versus 111 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Barco N.V.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 37); PGY (Display, Diagnostic Radiology, 12); DXJ (Display, Cathode-Ray Tube, Medical, 5).
Next steps
- See all 60 Barco N.V. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Barco N.V.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.