Cleared Traditional

K031515 - SPIROPRO SPO2

K031515 is an FDA 510(k) clearance for SPIROPRO SPO2, manufactured by Viasys Healthcare GmbH. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K031515 · Viasys Healthcare GmbH · Anesthesiology device
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Nov 2003
Decision
184d
Days
Class 2
Risk

K031515 is an FDA 510(k) clearance for the SPIROPRO SPO2. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Viasys Healthcare GmbH (Yorba Linda, US). The FDA issued a Cleared decision on November 14, 2003 after a review of 184 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 Viasys Healthcare GmbH devices

FDA 510(k) Submission Details - K031515

510(k) Number K031515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2003
Decision Date November 14, 2003
Days to Decision 184 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
44d slower than avg
Panel avg: 140d · This submission: 184d
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 K031515.
AC-1 SP02 ADAPTOR CABLE, MODEL AC-1
K033349 · Masimo Corp. · Jan 2004
SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS
K033298 · Masimo Corp. · Dec 2003
DRAEGER MICRO2+ AND MASIMO MINISAT
K032537 · Draeger Medical Systems, Inc. · Nov 2003
MODEL 3100 WRISTOX PULSE OXIMETER
K030668 · Nonin Medical, Inc. · Oct 2003
MODEL 9600, AVANT PULSE OXIMETER
K023044 · Nonin Medical, Inc. · Jul 2003
PICOSAT II SPO2 PULSE OXIMETRY MODULE
K030973 · Philips Medical Systems · Jul 2003