Cleared Special

K093881 - TRUSIGNAL SPO2 FINGER SENSOR

K093881 is an FDA 510(k) clearance for TRUSIGNAL SPO2 FINGER SENSOR, manufactured by GE Healthcare Finland Oy. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 84-day FDA review.

K093881 · GE Healthcare Finland Oy · Anesthesiology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K093881

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

DQA Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00881829 Unknown Observational

Hypoxia Blood Validation in Multiple Pulse Oximeters

Accuracy Validation in Multiple SpO2 Systems

500
Patients (est.)
1
Site
Condition studied Hypoxia
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator David Ransom, MD
Sponsor Clinimark, LLC
Started 2016-08-09 → Primary completion 2021-12-21
Primary outcome
Completion of study by all subjects
View full study on ClinicalTrials.gov

Regulatory Peers - DQA Oximeter

All 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K093881.
MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D
K100617 · Masimo Corporation · May 2010
HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M
K100203 · Beijing Choice Electronic Technololgy Co., Ltd. · May 2010
LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS
K094046 · Masimo Corporation · May 2010
SINGLE-PATIENT USE DISPOSABLE SENSOR
K093306 · Nonin Medical, Inc. · Mar 2010
MD300C1 FINGERTIP PULSE OXIMETER
K093757 · Beijing Choice Electronic Technololgy Co., Ltd. · Mar 2010
FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA
K092652 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2010