Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). (K261469): 510(k) cleared for Barco N.V.
Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). (K261469): 510(k) cleared for Barco N.V.: 510(k) cleared for Barco N.V. Its amount of 149 is above the median of 138 (55th percentile). Dated 36 days ago, it serves as a historical benchmark. Score 36/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 149 · 55th percentile of 414 FDAPulse records · 1.1x the median
Free preview: all 14 published fields of this record are shown below. Locked: 4 related BE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261469 |
| Device | Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). |
| Applicant | Barco N.V. |
| Specialty / panel | Cardiovascular |
| Product code | DXJ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-04 |
| Decision date | 2026-09-30 |
| Review time (days) | 149 |
| Third-party review | No |
| Applicant location | Kortrijk, BE |
| amount percentile | 55th of 414 (median 138, 1.1x median) |
| Peer records CSV (5 BE records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-30
- Data refreshed: 2026-11-04
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Top FDAPulse records (BE first): Wishbone HAE (K260096) · CMF Titanium Splints (K260913) · Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-663 · HipStudio Analysis (K262442) · SmartIPL_NI System (K241973) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 21:30:53 GMT
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Peer benchmark and outreach value: Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). (K261469): 510(k) cleared for Barco N.V. and 5 BE peers
- BE FDAPulse records like this one: 5
- Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). (K261469): 510(k) cleared for Barco N.V.'s amount: 55th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every BE peer: $1,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 149-day review: this device is a strong predicate for similar products.
- Posted 36 days ago.
What is the FDAPulse record for Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). (K261469): 510(k) cleared for Barco N.V.?
Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). (K261469) by Barco N.V. was cleared on 2026-09-30 after 149 days of review.
How does Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). (K261469): 510(k) cleared for Barco N.V. compare to other FDAPulse records?
Its amount of 149 sits in the upper half (55th percentile) of 414 records; the median is 138. It is 36 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). (K261469) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). (K261469) | BE | 2026-09-30 |
| TriSalus TriNav Advance Infusion System (K253509) | CO | 2026-09-21 |
| Hemotag Analysis Software (HAS) (K252736) | FL | 2026-10-21 |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 |
Related records
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Cardiovascular devices
How to monitor Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). (K261469): 510(k) cleared for Barco N.V. and peer cardiovascular records
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