Cleared Special

K151681 - IntelliVue Patient Monitor

K151681 is an FDA 510(k) clearance for IntelliVue Patient Monitor, manufactured by Philips Medizin Systeme Boeblingen GmbH. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Special 510(k) pathway after a 25-day FDA review.

K151681 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular device
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Jul 2015
Decision
25d
Days
Class 2
Risk

K151681 is an FDA 510(k) clearance for the IntelliVue Patient Monitor. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on July 17, 2015 after a review of 25 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 Philips Medizin Systeme Boeblingen GmbH devices

FDA 510(k) Submission Details - K151681

510(k) Number K151681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2015
Decision Date July 17, 2015
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
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 299
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K151681.
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM
K152550 · Medicalgorithmics S.A. · Oct 2015
BodyGuardian Remote Monitoring System
K151188 · Preventice · Sep 2015
CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
K143359 · Lifewatch Technologies , Ltd. · Sep 2015
Medtronic Patient Asistant
K150117 · Medtronic, Inc. · May 2015
IntelliVue Patient Monitor
K150310 · Philips Medizin Systeme Boeblingen GmbH · May 2015
CardiacLinx
K142352 · Ross Medical Technology, Inc. · Mar 2015