Cleared Traditional

K261469 - Nexxis 2

Also marketed or referenced as:
Nexxis OR 2 NMS 2 MNA-240 MNA-4x0 (Where “x” may be any numeric character).

K261469 is an FDA 510(k) clearance for Nexxis 2, manufactured by Barco N.V.. The device is a Class 2 General & Plastic Surgery device with product code DXJ cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K261469 · Barco N.V. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
149d
Days
Class 2
Risk

K261469 is an FDA 510(k) clearance for the Nexxis 2. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on September 30, 2026 after a review of 149 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 870.2450 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Barco N.V. devices

FDA 510(k) Submission Details - K261469

510(k) Number K261469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2026
Decision Date September 30, 2026
Days to Decision 149 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 115d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXJ Device Classification - Class 2, Special Controls

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - DXJ Display, Cathode-ray Tube, Medical

All 67
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K261469.
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Vios Central Station Monitor Software, Vios Central Server Software
K173107 · Vios Medical, Inc. · Jul 2018
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K180534 · Philips Medizin Systeme Boeblingen GmbH · Jul 2018
Nexxis OR
K173381 · Barco N.V. · Feb 2018