Cleared Traditional

N-600X WITH SPD, OXIMAX N-600X (K083325) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K083325 · Covidien · Anesthesiology device
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Mar 2009
Decision
117d
Days
Class 2
Risk

K083325 is an FDA 510(k) clearance for the N-600X WITH SPD, OXIMAX N-600X. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on March 9, 2009 after a review of 117 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 Covidien devices

Submission Details

510(k) Number K083325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2008
Decision Date March 09, 2009
Days to Decision 117 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
23d faster than avg
Panel avg: 140d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00775346 Completed Observational Industry-sponsored

A Multi-Center Study to Assess the Performance of Saturation Patterns.

A Multi-Center Study to Assess the Performance of the Saturation Pattern Detection (SPD) Software Algorithm.

92
Patients (actual)
3
Sites
Condition studied Sleep-Disordered Breathing; Obstructive Sleep Apnea; Sleep Apnea; Central Sleep Apnea
Eligibility All sexes · 18 Years+
Principal investigator Roger S Mecca, MD
Sponsor Medtronic - MITG (industry)
Started 2008-08-01 → Primary completion 2008-10-01
Primary outcome
Sensitivity and Specificity Data of the Saturation Pattern Detection (SPD) Feature as a Predictor of Repetitive Reductions in Airflow (RRiA).
View full study on ClinicalTrials.gov

Regulatory Peers - DQA Oximeter

All 170
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K083325.
BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
K121806 · Covidien · Sep 2012
VTRUST FINGER TYPE PULSE OXIMETER
K110893 · Taidoc Technology Corporation · Nov 2011
V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201
K101012 · Taidoc Technology Corporation · Dec 2010
PM-60 PULSE OXIMETER
K072581 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2008
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
K072235 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2007
PULSE OXIMETER, MODEL PM-50
K061442 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2006