Cleared Traditional

MIROXI (K081033) - FDA 510(k) Clearance

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

K081033 · Mir Medical Intl. Research Srl · Anesthesiology device
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Jan 2009
Decision
279d
Days
Class 2
Risk

K081033 is an FDA 510(k) clearance for the MIROXI. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Mir Medical Intl. Research Srl (Roma, IT). The FDA issued a Cleared decision on January 15, 2009 after a review of 279 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 Mir Medical Intl. Research Srl devices

Submission Details

510(k) Number K081033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2008
Decision Date January 15, 2009
Days to Decision 279 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
139d slower than avg
Panel avg: 140d · This submission: 279d
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 197
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K081033.
H100B PULSE OXIMETER
K092727 · Edan Instruments, Inc. · Dec 2009
VITAL SIGNS MONITOR
K083821 · Edan Instruments, Inc. · May 2009
N-600X WITH SPD, OXIMAX N-600X
K083325 · Covidien · Mar 2009
PM-60 PULSE OXIMETER
K072581 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2008
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
K072235 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2007
PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
K063783 · Philips Medical Systems, Inc. · Apr 2007