Nihon Kohden NKV-550 Series Ventilator System— 510(k) K231778

Name: FDA 510(k) clearance K231778
Creator: U.S. Food and Drug Administration
Published: 2024-03-01

Substantially Equivalent

Nihon Kohden Orangemed, LLC

FDA 510(k) clearance K231778 for Nihon Kohden NKV-550 Series Ventilator System, Substantially Equivalent on 2024-03-01. Applicant: Nihon Kohden Orangemed, LLC. Device class: 2.

Clearance details

Applicant: Nihon Kohden Orangemed, LLC
Product code: Code CBK
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2023-06-16
Decision date: 2024-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.