Cleared Traditional

ASSURANCE ALAR SENSOR MODEL 10078 (K122996) - FDA 510(k) Clearance

Also marketed or referenced as:
AB-N ADAPTER CABLE MODEL 10085

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

K122996 · Xhale · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
195d
Days
Class 2
Risk

K122996 is an FDA 510(k) clearance for the ASSURANCE ALAR SENSOR MODEL 10078. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Xhale (Glastonbury, US). The FDA issued a Cleared decision on April 10, 2013 after a review of 195 days - an extended review 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: 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 devices

Submission Details

510(k) Number K122996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2012
Decision Date April 10, 2013
Days to Decision 195 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
55d slower than avg
Panel avg: 140d · This submission: 195d
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 203
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K122996.
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IHEALTH FINGERTIP PULSE OXIMETER
K131111 · Andon Health Co, Ltd. · Sep 2013
VITAL SIGNS MONITOR
K131818 · Edan Instruments, Inc. · Aug 2013
FINGERTIP PULSE OXIMETER
K121697 · Andon Health Co, Ltd. · Oct 2012
BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
K121806 · Covidien · Sep 2012
NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM
K120773 · Covidien, LLC · Jul 2012