Cleared Traditional

K233251 - NOxBOXi Nitric Oxide Delivery System (FDA 510(k) Clearance)

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

K233251 · Linde Gas & Equipment, Inc. · Anesthesiology device
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May 2024
Decision
238d
Days
Class 2
Risk

K233251 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. (Livingston, US). The FDA issued a Cleared decision on May 23, 2024 after a review of 238 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5165 - 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 Linde Gas & Equipment, Inc. devices

Submission Details

510(k) Number K233251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date May 23, 2024
Days to Decision 238 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
99d slower than avg
Panel avg: 139d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Brittany Dunning

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 K233251.
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
Evolve Nitric Oxide Delivery System
K222930 · Mallinckrodt Manufacturing, LLC · Dec 2023
NOxBOXi Nitric Oxide Delivery System
K231823 · Linde Gas & Equipment, Inc. · Aug 2023
Ulspira TS Nitric Oxide Therapy System
K212409 · Airgas Therapeutics · Jun 2023