Cleared Traditional

K143216 - Assurance Alar / Nasal SpO2 Sensor

K143216 is an FDA 510(k) clearance for Assurance Alar / Nasal SpO2 Sensor, manufactured by Xhale, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K143216 · Xhale, Inc. · Anesthesiology device
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Mar 2015
Decision
127d
Days
Class 2
Risk

K143216 is an FDA 510(k) clearance for the Assurance Alar / Nasal 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 March 17, 2015 after a review of 127 days - within the typical 510(k) review window.

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: 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 Xhale, Inc. devices

FDA 510(k) Submission Details - K143216

510(k) Number K143216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2014
Decision Date March 17, 2015
Days to Decision 127 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
13d faster than avg
Panel avg: 140d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

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 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K143216.
Masimo MightySat Rx Fingertip Pulse Oximeter
K150314 · Masimo Corporation · Oct 2015
Fingertip Pulse Oximeter
K151206 · Beijing Choice Electronic Technololgy Co., Ltd. · Aug 2015
Nellcor Bedside SpO2 Patient Monitoring System
K142865 · Covidien, LLC · Mar 2015
Nellcor Bedside Respiratory Patient Monitoring System
K141518 · Covidien · Mar 2015
Fingertip Pulse Oximeter
K142888 · Beijing Choice Electronic Technololgy Co., Ltd. · Feb 2015
Unimed Disposable and Reusable SPO2 Sensors
K142832 · Unimed Medical Supplies, Inc. · Feb 2015