Cleared Special

TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR (K093881) - FDA 510(k) Clearance

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

K093881 · GE Healthcare Finland Oy · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Mar 2010
Decision
84d
Days
Class 2
Risk

K093881 is an FDA 510(k) clearance for the TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP .... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on March 12, 2010 after a review of 84 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 K093881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2009
Decision Date March 12, 2010
Days to Decision 84 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
56d faster than avg
Panel avg: 140d · This submission: 84d
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 K093881.
BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
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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