Cleared Special

MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO (K081870) - FDA 510(k) Clearance

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

K081870 · GE Healthcare Finland Oy · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
30d
Days
Class 2
Risk

K081870 is an FDA 510(k) clearance for the MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by GE Healthcare Finland Oy (Milwaukee, US). The FDA issued a Cleared decision on July 31, 2008 after a review of 30 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 GE Healthcare Finland Oy devices

Submission Details

510(k) Number K081870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2008
Decision Date July 31, 2008
Days to Decision 30 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
110d faster than avg
Panel avg: 140d · This submission: 30d
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 171
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K081870.
VTRUST FINGER TYPE PULSE OXIMETER
K110893 · Taidoc Technology Corporation · Nov 2011
V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201
K101012 · Taidoc Technology Corporation · Dec 2010
N-600X WITH SPD, OXIMAX N-600X
K083325 · Covidien · Mar 2009
PM-60 PULSE OXIMETER
K072581 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2008
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
K072235 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2007
PULSE OXIMETER, MODEL PM-50
K061442 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2006