Cleared Special

SINGLE-PATIENT USE DISPOSABLE SENSOR (K093306) - FDA 510(k) Clearance

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

K093306 · Nonin Medical, Inc. · Anesthesiology device
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Mar 2010
Decision
133d
Days
Class 2
Risk

K093306 is an FDA 510(k) clearance for the SINGLE-PATIENT USE DISPOSABLE SENSOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 4, 2010 after a review of 133 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nonin Medical, Inc. devices

Submission Details

510(k) Number K093306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2009
Decision Date March 04, 2010
Days to Decision 133 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
7d faster than avg
Panel avg: 140d · This submission: 133d
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 176
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