Cleared Traditional

K171696 - NOxBOXi Nitric Oxide Delivery System

K171696 is an FDA 510(k) clearance for NOxBOXi Nitric Oxide Delivery System, manufactured by Praxair Distribution, Inc.. The device is a Class 2 Anesthesiology device with product code MRN cleared through the Traditional 510(k) pathway after a 482-day FDA review.

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

FDA 510(k) Submission Details - K171696

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
342d slower than avg
Panel avg: 140d · This submission: 482d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRN Device Classification - Class 2, Special Controls

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 Peers - MRN Apparatus, Nitric Oxide Delivery

All 14
Devices cleared under the same product code (MRN) and FDA review panel - the closest regulatory comparables to K171696.
The NOxBOXi Nitric Oxide Delivery System
K201339 · Praxair, Inc. · Jun 2020
INOmax DSIR Plus
K200389 · Mallinckrodt Manufacturing, LLC · Jun 2020
AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
K193481 · International Biomedical · Mar 2020
DATEX-OHMEDA INOVENT DELIVERY SYSTEM
K000186 · Datex-Ohmeda · Feb 2000
OHMEDA INOVENT DELIVERY SYSTEM
DEN000001 · Ohmeda Medical · Jan 2000