Cleared Traditional

K090807 - REGIONAL OXIMETER SYSTEM

K090807 is an FDA 510(k) clearance for REGIONAL OXIMETER SYSTEM, manufactured by Nonin Medical, Inc.. The device is a Class 2 Cardiovascular device with product code MUD cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K090807 · Nonin Medical, Inc. · Cardiovascular device
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Jun 2009
Decision
97d
Days
Class 2
Risk

K090807 is an FDA 510(k) clearance for the REGIONAL OXIMETER SYSTEM, MODEL 7600. Classified as Oximeter, Tissue Saturation (product code MUD), Class II - Special Controls.

Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 30, 2009 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Nonin Medical, Inc. devices

FDA 510(k) Submission Details - K090807

510(k) Number K090807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2009
Decision Date June 30, 2009
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUD Device Classification - Class 2, Special Controls

Product Code MUD Oximeter, Tissue Saturation
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - MUD Oximeter, Tissue Saturation

All 38
Devices cleared under the same product code (MUD) and FDA review panel - the closest regulatory comparables to K090807.
FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030
K094030 · Cas Medical Systems, Inc. · Dec 2010
REGIONAL OXIMETER
K102715 · Nonin Medical, Inc. · Dec 2010
FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030)
K091452 · Cas Medical Systems, Inc. · Aug 2009
FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040
K061960 · Cas Medical Systems, Inc. · Sep 2006