Cleared Traditional

Nasal Alar SpO2 Sensor (K171423) - FDA 510(k) Clearance

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

K171423 · Xhale, Inc. · Anesthesiology device
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Jul 2017
Decision
73d
Days
Class 2
Risk

K171423 is an FDA 510(k) clearance for the Nasal Alar SpO2 Sensor. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Xhale, Inc. (Gainesville, US). The FDA issued a Cleared decision on July 27, 2017 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Xhale, Inc. devices

Submission Details

510(k) Number K171423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2017
Decision Date July 27, 2017
Days to Decision 73 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 140d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 200
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K171423.
Pulse Oximeter
K171241 · Hunan Accurate Bio-Medical Technology Co., Ltd. · Mar 2018
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K172366 · Beijing Choice Electronic Technology Co., Ltd. · Mar 2018
The Nellcor pulse oximetry monitor interface cable
K172482 · Covidien · Dec 2017
Finger Type Pulse Oximeter
K151024 · Taidoc Technology Corporation · Mar 2016
Nellcor Bedside SpO2 Patient Monitoring System
K142865 · Covidien, LLC · Mar 2015
Nellcor Bedside Respiratory Patient Monitoring System
K141518 · Covidien · Mar 2015