Cleared Traditional

K231778 - Nihon Kohden NKV-550 Series Ventilator ...

K231778 is an FDA 510(k) clearance for Nihon Kohden NKV-550 Series Ventilator ..., manufactured by Nihon Kohden Orangemed, LLC. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K231778 · Nihon Kohden Orangemed, LLC · Anesthesiology device
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Mar 2024
Decision
259d
Days
Class 2
Risk

K231778 is an FDA 510(k) clearance for the Nihon Kohden NKV-550 Series Ventilator System. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Nihon Kohden Orangemed, LLC (Santa Ana, US). The FDA issued a Cleared decision on March 1, 2024 after a review of 259 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nihon Kohden Orangemed, LLC devices

FDA 510(k) Submission Details - K231778

510(k) Number K231778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2023
Decision Date March 01, 2024
Days to Decision 259 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 140d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 278
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K231778.
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K213098 · Origin Medical Devices · Jul 2023
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K220107 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2023
Nihon Kohden NKV-440 Ventilator System
K222644 · Nihon Kohden Orangemed, Inc. · May 2023