Cleared Traditional

K083325 - N-600X WITH SPD

K083325 is an FDA 510(k) clearance for N-600X WITH SPD, manufactured by Covidien. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K083325 · Covidien · Anesthesiology device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K083325

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.

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. 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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K083325.
MD2000A VITAL SIGN MONITOR, MODEL MD2000A
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LNCS OXIMETRY SENSORS
K083622 · Masimo Corporation · Apr 2009
FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)
K083892 · Cas Medical Systems, Inc. · Mar 2009
M-50 SERIES SPO2 SENSOR
K082487 · Beijing Choice Electronic Technololgy Co., Ltd. · Mar 2009
INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997
K082888 · Draeger Medical Systems, Inc. · Nov 2008
MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK
K082052 · Masimo Corporation · Oct 2008