Cleared Traditional

SPIROPRO SPO2 (K031515) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 240
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K031515.
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT
K041674 · Philips Medical Systems · Jul 2004
PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
K032979 · Philips Medical Systems, Inc. · Feb 2004
PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
K033715 · Philips Medical Systems, Inc. · Feb 2004
PICOSAT II SPO2 PULSE OXIMETRY MODULE
K030973 · Philips Medical Systems · Jul 2003
SIEMENS MICRO2+ WITH VAI SOFTWARE
K030640 · Siemens Medical Solutions USA, Inc. · Jun 2003
ATLAS MONITOR, MODELS 200,210,220
K022084 · Welch Allyn, Inc. · Sep 2002