Cleared Traditional

NOxBOXi Nitric Oxide Delivery System (K171696) - FDA 510(k) Clearance

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

K171696 · Praxair Distribution, Inc. · Anesthesiology device
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Oct 2018
Decision
482d
Days
Class 2
Risk

K171696 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 Praxair Distribution, Inc. (Danbury, US). The FDA issued a Cleared decision on October 2, 2018 after a review of 482 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Praxair Distribution, Inc. devices

Submission Details

510(k) Number K171696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2017
Decision Date October 02, 2018
Days to Decision 482 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
343d slower than avg
Panel avg: 139d · This submission: 482d
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.