Cleared Traditional

Oxitone 1000 (K163382) - FDA 510(k) Clearance

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

K163382 · Oxitone Medical , Ltd. · Anesthesiology device
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May 2017
Decision
159d
Days
Class 2
Risk

K163382 is an FDA 510(k) clearance for the Oxitone 1000. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Oxitone Medical , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on May 9, 2017 after a review of 159 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 Oxitone Medical , Ltd. devices

Submission Details

510(k) Number K163382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2016
Decision Date May 09, 2017
Days to Decision 159 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
19d slower than avg
Panel avg: 140d · This submission: 159d
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 K163382.
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The Nellcor pulse oximetry monitor interface cable
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Finger Type Pulse Oximeter
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Nellcor Bedside SpO2 Patient Monitoring System
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Nellcor Bedside Respiratory Patient Monitoring System
K141518 · Covidien · Mar 2015