510(k) · Cleared
ClearedNexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character).
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barco N.V. · DXJ Display, Cathode-Ray Tube, Medical
Cleared on Sep 30, 2026 as substantially equivalent to K173381 (Barco N.V., 2018) after a 149-day review. Its family tree reaches back 3 generations to 2013.
- Decided
- Sep 30, 2026
- Review
- 149 days
- Class
- Class II
- Product code
- DXJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K122167 (2013). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K122167 | Nexxis or | Barco N.V. | 2013 | — |
| −2 | K170537 | Nexxis OR, Nexxis | Barco N.V. | 2017 | — |
| −1 | K173381 | Nexxis OR | Barco N.V. | 2018 | 3 |
| 0 (this device) | K261469 | Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric… | Barco N.V. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXJ device
- #1 K212208 Philips IntelliVue GuardianSoftware (Rev. E.0X)score 11.8 · 36 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173381 | Nexxis ORSummary page 5…r 870.2450 Product Code(s) DXJ I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K173381 Nexxis OR, Nexxis, NMS, MNA-110, MNA-120, MNA-240 DXJ Device Description Summary 21 CFR 807.92(a)(4) Nexxis OR 2.x is Barco's ne… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 1 company; a new generation was cleared every 4.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All DXJ devicesDXJ Display, Cathode-Ray Tube, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DXJ
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DXJ
130in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXJ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXJ
3in 2025
MAUDE reports naming product code DXJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 8 | 29 |
| 2010 | 2 | — | 1 | 148 |
| 2011 | 4 | 53 | 1 | 129 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 3 | 174 | 0 | 4 |
| 2014 | 4 | 242 | 0 | 13 |
| 2015 | 2 | — | 0 | 15 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 4 | 164 | 0 | 10 |
| 2018 | 4 | 130 | 0 | 3 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 22 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V signals and medical images from various commercially available instruments that are commonly used in a medical procedure laboratory or operating room. The Barco Nexxis OR system is also designed for transfer, selection and distribution of human interface signals and control signals of non-medical room equipment, The Barco Nexxis OR system allows control and…
Read the full statement (117 words)
The Barco Nexxis OR system is designed to allow transfer, selection and distribution of A/V signals and
medical images from various commercially available instruments that are commonly used in a medical
procedure laboratory or operating room.
The Barco Nexxis OR system is also designed for transfer, selection and distribution of human interface
signals and control signals of non-medical room equipment,
The Barco Nexxis OR system allows control and selection of these signals from a central point.
The Barco Nexxis OR system is not intended to be used for remote or robotically assisted surgery,
The Barco Nexxis OR system is not intended to be used in the vicinity of MRI or other devices that use
strong magnetic fields.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261469: Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character)..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261469
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026