Cleared Special

K141113 - SPACELBS MODEL ON TRAK (90227) AMBULATO...

K141113 is an FDA 510(k) clearance for SPACELBS MODEL ON TRAK (90227) AMBULATO..., manufactured by Spacelabs Healthcare, Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 149-day FDA review.

K141113 · Spacelabs Healthcare, Ltd. · Cardiovascular device
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Sep 2014
Decision
149d
Days
Class 2
Risk

K141113 is an FDA 510(k) clearance for the SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Spacelabs Healthcare, Ltd. (Nederland, US). The FDA issued a Cleared decision on September 26, 2014 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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. Standard predicate reliance. 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 Healthcare, Ltd. devices

FDA 510(k) Submission Details - K141113

510(k) Number K141113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2014
Decision Date September 26, 2014
Days to Decision 149 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
24d slower than avg
Panel avg: 125d · This submission: 149d
Pathway characteristics
Modification to existing cleared device.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

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