Cleared Special

K103732 - SPACELABS MODEL 90217A AMBULATORY BLOOD...

K103732 is an FDA 510(k) clearance for SPACELABS MODEL 90217A AMBULATORY BLOOD..., 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 44-day FDA review.

K103732 · Spacelabs Healthcare, Ltd. · Cardiovascular device
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Feb 2011
Decision
44d
Days
Class 2
Risk

K103732 is an FDA 510(k) clearance for the SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR. 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 February 4, 2011 after a review of 44 days - a notably fast clearance cycle.

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. 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 Healthcare, Ltd. devices

FDA 510(k) Submission Details - K103732

510(k) Number K103732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2010
Decision Date February 04, 2011
Days to Decision 44 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
81d faster than avg
Panel avg: 125d · This submission: 44d
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

All 566
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