Cleared Special

K062278 - SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 (FDA 510(k) Clearance)

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

K062278 · Spacelabs Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
43d
Days
Class 2
Risk

K062278 is an FDA 510(k) clearance for the SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Spacelabs Medical, Inc. (Issaquah, US). The FDA issued a Cleared decision on September 19, 2006 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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

Submission Details

510(k) Number K062278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2006
Decision Date September 19, 2006
Days to Decision 43 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

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