Cleared Special

K092950 - SOLARIS MODELS NT1 AND NT1A HANDHELD PU...

K092950 is an FDA 510(k) clearance for SOLARIS MODELS NT1 AND NT1A HANDHELD PU..., manufactured by Solaris Medical Technology, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 169-day FDA review.

K092950 · Solaris Medical Technology, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
169d
Days
Class 2
Risk

K092950 is an FDA 510(k) clearance for the SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Solaris Medical Technology, Inc. (Great Neck, US). The FDA issued a Cleared decision on March 12, 2010 after a review of 169 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Solaris Medical Technology, Inc. devices

FDA 510(k) Submission Details - K092950

510(k) Number K092950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2009
Decision Date March 12, 2010
Days to Decision 169 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
29d slower than avg
Panel avg: 140d · This submission: 169d
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. 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 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K092950.
MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D
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K093881 · GE Healthcare Finland Oy · Mar 2010
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K093306 · Nonin Medical, Inc. · Mar 2010
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K093757 · Beijing Choice Electronic Technololgy Co., Ltd. · Mar 2010