Cleared Special

REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES (K092101) - FDA 510(k) Clearance

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

K092101 · Nonin Medical, Inc. · Anesthesiology device
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Oct 2009
Decision
99d
Days
Class 2
Risk

K092101 is an FDA 510(k) clearance for the REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 21, 2009 after a review of 99 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 K092101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2009
Decision Date October 21, 2009
Days to Decision 99 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
41d faster than avg
Panel avg: 140d · This submission: 99d
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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BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
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K072581 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2008
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K072235 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2007