Cleared Special

K163649 - SureSigns VS3

Also marketed or referenced as:
SureSigns VS4

K163649 is an FDA 510(k) clearance for SureSigns VS3, manufactured by Philips Medical Systems. The device is a Class 2 Cardiovascular device with product code DSJ cleared through the Special 510(k) pathway after a 98-day FDA review.

K163649 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
98d
Days
Class 2
Risk

K163649 is an FDA 510(k) clearance for the SureSigns VS3. Classified as Alarm, Blood-pressure (product code DSJ), Class II - Special Controls.

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on March 31, 2017 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1100 - 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.

FDA 510(k) Submission Details - K163649

510(k) Number K163649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2016
Decision Date March 31, 2017
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

DSJ Device Classification - Class 2, Special Controls

Product Code DSJ Alarm, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1100
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 - DSJ Alarm, Blood-pressure

Devices cleared under the same product code (DSJ) and FDA review panel - the closest regulatory comparables to K163649.
EarlyVue VS30
K190624 · Philips Medizin Systeme Boeblingen GmbH · Oct 2019
SureSigns VS3, SureSigns VS4
K151761 · Phillips Medical Systems · Sep 2015
SURESIGNS VS3, SURESIGNS VS4
K133961 · Philips Medical Systems · Jun 2014
SAMS 8000 CARDIOPLEGIA MONITOR
K960916 · 3M Health Care, Sarns · Jun 1996
KELLER VITAL SIGNS MONITOR - KMS-890
K910262 · Keller Medical Specialties Products, Inc. · Apr 1991
K163649 · SureSigns VS3
Download PDF FDA Summary Philips Medical Syste…