Cleared Special

K082888 - INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 (FDA 510(k) Clearance)

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

K082888 · Draeger Medical Systems, Inc. · Anesthesiology device
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Nov 2008
Decision
57d
Days
Class 2
Risk

K082888 is an FDA 510(k) clearance for the INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Draeger Medical Systems, Inc. (Andover, US). The FDA issued a Cleared decision on November 26, 2008 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Draeger Medical Systems, Inc. devices

Submission Details

510(k) Number K082888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2008
Decision Date November 26, 2008
Days to Decision 57 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 139d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

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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