Cleared Special

K050175 - SPACELABS MEDICAL MULTIPARAMETER MODULE...

K050175 is an FDA 510(k) clearance for SPACELABS MEDICAL MULTIPARAMETER MODULE..., manufactured by Spacelabs Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Special 510(k) pathway after a 37-day FDA review.

K050175 · Spacelabs Medical, Inc. · Cardiovascular device
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Mar 2005
Decision
37d
Days
Class 2
Risk

K050175 is an FDA 510(k) clearance for the SPACELABS MEDICAL MULTIPARAMETER MODULE 91496. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Spacelabs Medical, Inc. (Issaquah, US). The FDA issued a Cleared decision on March 4, 2005 after a review of 37 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 - K050175

510(k) Number K050175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2005
Decision Date March 04, 2005
Days to Decision 37 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
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

DSI Device Classification - Class 2, Special Controls

Product Code DSI Detector And Alarm, Arrhythmia
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 - DSI Detector And Alarm, Arrhythmia

All 238
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K050175.
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SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
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