Cleared Traditional

K061931 - SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101

K061931 is an FDA 510(k) clearance for SOLARIS COMPATIBLE REUSABLE ADULT SPO2 ..., 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 208-day FDA review.

K061931 · Solaris Medical Technology, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
208d
Days
Class 2
Risk

K061931 is an FDA 510(k) clearance for the SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AN.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Solaris Medical Technology, Inc. (Las Vegas, US). The FDA issued a Cleared decision on January 31, 2007 after a review of 208 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.

FDA 510(k) Submission Details - K061931

510(k) Number K061931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2006
Decision Date January 31, 2007
Days to Decision 208 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
68d slower than avg
Panel avg: 140d · This submission: 208d
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 686
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K061931.
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MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N
K061896 · Mediaid, Inc. · Apr 2007
CADWELL EASYNET OXIMETER MODULE
K061706 · Cadwell Laboratories, Inc. · Mar 2007
TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
K063434 · Radiometer Basel AG · Jan 2007
RAINBOW ADHESIVE CO-OXIMETRY SENSORS
K063140 · Masimo Corporation · Dec 2006
TENACORE SP02 SENSORS
K053420 · Tenacore Holdings, Inc. · Nov 2006