Cleared Special

K123900 - SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8

K123900 is an FDA 510(k) clearance for SURESIGNS VM4, manufactured by Philips Medical Systems. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Special 510(k) pathway after a 121-day FDA review.

K123900 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
121d
Days
Class 2
Risk

K123900 is an FDA 510(k) clearance for the SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on April 18, 2013 after a review of 121 days - within the typical 510(k) review window.

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. 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 - K123900

510(k) Number K123900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2012
Decision Date April 18, 2013
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Modification to existing cleared device.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 428
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K123900.
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K130711 · Draeger Medical Systems, Inc. · Apr 2013
PROCARE MONITOR B20
K122253 · Ge Medical Systems China Co., Ltd. · Mar 2013
MORTARA SURVEYOR PATIENT MONITOR
K123556 · Mortara Instrument, Inc. · Mar 2013
K123900 · SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
Download PDF FDA Summary Philips Medical Syste…