Cleared Special

K220898 - NOxBOXi Nitric Oxide Delivery System (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K220898 · Linde Gas & Equipment, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
30d
Days
Class 2
Risk

K220898 is an FDA 510(k) clearance for the NOxBOXi Nitric Oxide Delivery System. Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Linde Gas & Equipment, Inc. (Tonawanda, US). The FDA issued a Cleared decision on April 27, 2022 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5165 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Linde Gas & Equipment, Inc. devices

Submission Details

510(k) Number K220898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2022
Decision Date April 27, 2022
Days to Decision 30 days
Submission Type Special
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
109d faster than avg
Panel avg: 139d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MRN Apparatus, Nitric Oxide Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5165
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 Consultant

Emergo Global Consulting, LLC
Olga Lewis

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MRN Apparatus, Nitric Oxide Delivery

All 32
Devices cleared under the same product code (MRN) and FDA review panel - the closest regulatory comparables to K220898.
ULSPIRA TS™ Nitric Oxide Therapy System
K242374 · Airgas Therapeutics, LLC · Jan 2025
EVOLVE Nitric Oxide Delivery System
K242578 · Mallinckrodt Manufacturing, LLC · Jan 2025
EVOLVE Nitric Oxide Delivery System
K240410 · Malinckrodt Manufacturing, LLC · May 2024
NOxBOXi Nitric Oxide Delivery System
K233251 · Linde Gas & Equipment, Inc. · May 2024
Evolve Nitric Oxide Delivery System
K222930 · Mallinckrodt Manufacturing, LLC · Dec 2023
NOxBOXi Nitric Oxide Delivery System
K231823 · Linde Gas & Equipment, Inc. · Aug 2023