Cleared Special

K002957 - SOLAR SPO2 MODULE WITH MASIMO SET

K002957 is the FDA 510(k) clearance for SOLAR SPO2 MODULE WITH MASIMO SET by General Electric Medical Systems Information Techn. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Special 510(k) pathway after a 26-day FDA review.

K002957 · General Electric Medical Systems Information Techn · Anesthesiology device
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Oct 2000
Decision
26d
Days
Class 2
Risk

K002957 is an FDA 510(k) clearance for the SOLAR SPO2 MODULE WITH MASIMO SET. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by General Electric Medical Systems Information Techn (Milwaukee, US). The FDA issued a Cleared decision on October 18, 2000 after a review of 26 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 General Electric Medical Systems Information Techn devices

Submission Details

510(k) Number K002957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2000
Decision Date October 18, 2000
Days to Decision 26 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
114d faster than avg
Panel avg: 140d · This submission: 26d
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 407
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K002957.
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
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K010451 · Novametrix Medical Systems, Inc. · Apr 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
K010463 · Datex-Ohmeda, Inc. · Mar 2001
MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500
K002690 · Nonin Medical, Inc. · Oct 2000
MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500
K001930 · Nonin Medical, Inc. · Jul 2000
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
K001688 · Datex-Ohmeda, Inc. · Jun 2000