Cleared Traditional

K101871 - TRUSIGNAL SPO2 FINGERTIP SENSOR

K101871 is an FDA 510(k) clearance for TRUSIGNAL SPO2 FINGERTIP 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 90-day FDA review.

K101871 · GE Healthcare Finland Oy · Anesthesiology device
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Oct 2010
Decision
90d
Days
Class 2
Risk

K101871 is an FDA 510(k) clearance for the TRUSIGNAL SPO2 FINGERTIP 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 October 4, 2010 after a review of 90 days - within the typical 510(k) review window.

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 - K101871

510(k) Number K101871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2010
Decision Date October 04, 2010
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K101871.
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K100428 · Masimo Corporation · Jul 2010
MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7
K100403 · Masimo Corporation · Jun 2010