Cleared Abbreviated

K132026 - V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 (FDA 510(k) Clearance)

Class II Neurology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K132026 · Mindray DS USA, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 2013
Decision
172d
Days
Class 2
Risk

K132026 is an FDA 510(k) clearance for the V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Mindray DS USA, Inc. (Mahwh, US). The FDA issued a Cleared decision on December 20, 2013 after a review of 172 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1025 - the FDA neurology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Mindray DS USA, Inc. devices

Submission Details

510(k) Number K132026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2013
Decision Date December 20, 2013
Days to Decision 172 days
Submission Type Abbreviated
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 148d · This submission: 172d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 Neurology devices follow this clearance model.

Regulatory Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

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