Cleared Abbreviated

K070408 - DURAMAX REUSABLE OXIMETRY SENSOR (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K070408 · Nellcor Puritan Bennett, Inc. · Anesthesiology device
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May 2007
Decision
102d
Days
Class 2
Risk

K070408 is an FDA 510(k) clearance for the DURAMAX REUSABLE OXIMETRY SENSOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett, Inc. (Pleasanton, US). The FDA issued a Cleared decision on May 25, 2007 after a review of 102 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nellcor Puritan Bennett, Inc. devices

Submission Details

510(k) Number K070408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2007
Decision Date May 25, 2007
Days to Decision 102 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 139d · This submission: 102d
Pathway characteristics
Standards-based clearance path.

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 723
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