Cleared Special

SOLAR SPO2 MODULE WITH MASIMO SET (K002957) - FDA 510(k) Clearance

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

K002957 · General Electric Medical Systems Information Techn · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 139d · 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 155
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K002957.
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NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
K992455 · Nihon Kohden America, Inc. · Jan 2000
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K991661 · Siemens Medical Solutions USA, Inc. · May 1999
NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES
K974292 · Nihon Kohden America, Inc. · Jun 1998