Cleared Special

K112962 - SPACELABS HEALTHCARE XPREZZON BESIDE MO...

K112962 is an FDA 510(k) clearance for SPACELABS HEALTHCARE XPREZZON BESIDE MO..., manufactured by Spacelabs Medical, Inc.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Special 510(k) pathway after a 28-day FDA review.

K112962 · Spacelabs Medical, Inc. · Cardiovascular device
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Nov 2011
Decision
28d
Days
Class 2
Risk

K112962 is an FDA 510(k) clearance for the SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930). Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Spacelabs Medical, Inc. (Issaquah, US). The FDA issued a Cleared decision on November 2, 2011 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spacelabs Medical, Inc. devices

FDA 510(k) Submission Details - K112962

510(k) Number K112962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2011
Decision Date November 02, 2011
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

MHX Device Classification - Class 2, Special Controls

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 Cardiovascular devices follow this clearance model.

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

All 319
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