Cleared Abbreviated

K132036 - HYPERVISOR CENTRAL MONITORING SYSTEM (I...

K132036 is an FDA 510(k) clearance for HYPERVISOR CENTRAL MONITORING SYSTEM (I..., manufactured by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Abbreviated 510(k) pathway after a 365-day FDA review.

K132036 · Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
365d
Days
Class 2
Risk

K132036 is an FDA 510(k) clearance for the HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, .... Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. (Mahwh, US). The FDA issued a Cleared decision on July 1, 2014 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight 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 Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K132036

510(k) Number K132036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2013
Decision Date July 01, 2014
Days to Decision 365 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
240d slower than avg
Panel avg: 125d · This submission: 365d
Pathway characteristics
Standards-based clearance path.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - MSX System, Network And Communication, Physiological Monitors

All 74
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K132036.
CareEvent
K142935 · Philips Medical Systems · Jan 2015
INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION
K141756 · Draeger Medical Systems, Inc. · Dec 2014
M3290B Philips IntelliVue Information Center iX
K143057 · Philips Medical Systems · Dec 2014
ZOLL RESCUENET 12-LEAD
K121865 · ZOLL Medical Corporation · Nov 2012
INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00
K102974 · Philips Medical Systems · Jan 2011
PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441
K091176 · Philips Medical Systems · Nov 2009