Cleared Traditional

K103802 - TRUSIGNAL R SPO2 PEDITIP SENSOR

Also marketed or referenced as:
TRUSIGNAL R SPO2 PEDITIP SENSOR TRUSIGNAL R SPO2 PEDITIP SENSOR

K103802 is an FDA 510(k) clearance for TRUSIGNAL R SPO2 PEDITIP SENSOR, manufactured by GE Healthcare Finland Oy. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K103802 · GE Healthcare Finland Oy · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
217d
Days
Class 2
Risk

K103802 is an FDA 510(k) clearance for the TRUSIGNAL R SPO2 PEDITIP SENSOR. 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 August 2, 2011 after a review of 217 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all GE Healthcare Finland Oy devices

FDA 510(k) Submission Details - K103802

510(k) Number K103802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2010
Decision Date August 02, 2011
Days to Decision 217 days
Submission Type Traditional
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
77d slower than avg
Panel avg: 140d · This submission: 217d
Pathway characteristics
Predicate-based equivalence.

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 665
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K103802.
MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS
K111621 · Masimo Corporation · Oct 2011
MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS
K111888 · Masimo Corporation · Sep 2011
VITAL SIGNS MONITOR
K112465 · Advanced Instruments, Inc. · Sep 2011
DIXTAL DZ-4100 SERIES PULSE OXIMETER
K103285 · Dixtal Medical, Inc. · Jul 2011
PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA
K103685 · Beijing Rongrui-Century Scie. & Tech. Co., Ltd. · Jul 2011
ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
K103584 · Shenzhen Envisen Industry Co. Limited · Jun 2011