Cleared Traditional

K213521 - Nihon Kohden NKV-330 Ventilator System (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213521 · Nihon Kohden Orangemed, Inc. · Anesthesiology device
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Jul 2022
Decision
240d
Days
Class 2
Risk

K213521 is an FDA 510(k) clearance for the Nihon Kohden NKV-330 Ventilator System. Classified as Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (product code MNT), Class II - Special Controls.

Submitted by Nihon Kohden Orangemed, Inc. (Santa Ana, US). The FDA issued a Cleared decision on July 1, 2022 after a review of 240 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, Inc. devices

Submission Details

510(k) Number K213521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2021
Decision Date July 01, 2022
Days to Decision 240 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
101d slower than avg
Panel avg: 139d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNT Ventilator, Continuous, Minimal Ventilatory Support, 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 - MNT Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

All 24
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