Cleared Traditional

K073249 - SOLARIS NT1 AND NT1A HANDHELD PULSE OXI...

K073249 is an FDA 510(k) clearance for SOLARIS NT1 AND NT1A HANDHELD PULSE OXI..., manufactured by Solaris Medical Technology, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K073249 · Solaris Medical Technology, Inc. · Anesthesiology device
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Jul 2008
Decision
249d
Days
Class 2
Risk

K073249 is an FDA 510(k) clearance for the SOLARIS 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 July 25, 2008 after a review of 249 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 Solaris Medical Technology, Inc. devices

FDA 510(k) Submission Details - K073249

510(k) Number K073249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2007
Decision Date July 25, 2008
Days to Decision 249 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 140d · This submission: 249d
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 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K073249.
RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L
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