Cleared Traditional

K213521 - Nihon Kohden NKV-330 Ventilator System

K213521 is an FDA 510(k) clearance for Nihon Kohden NKV-330 Ventilator System, manufactured by Nihon Kohden Orangemed, Inc.. The device is a Class 2 Anesthesiology device with product code MNT cleared through the Traditional 510(k) pathway after a 240-day FDA review.

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

FDA 510(k) Submission Details - K213521

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
100d slower than avg
Panel avg: 140d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNT Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (MNT) and FDA review panel - the closest regulatory comparables to K213521.
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K121623 · Respironics, Inc. · Dec 2012
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