Cleared Traditional

K151812 - PATIENT MONITORS VARIOUS MODELS

K151812 is an FDA 510(k) clearance for PATIENT MONITORS VARIOUS MODELS, manufactured by Philips Medical Systems. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K151812 · Philips Medical Systems · Cardiovascular device
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Jan 2016
Decision
208d
Days
Class 2
Risk

K151812 is an FDA 510(k) clearance for the PATIENT MONITORS VARIOUS MODELS. 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 January 26, 2016 after a review of 208 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Philips Medical Systems devices

FDA 510(k) Submission Details - K151812

510(k) Number K151812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2015
Decision Date January 26, 2016
Days to Decision 208 days
Submission Type Traditional
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
83d slower than avg
Panel avg: 125d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 349
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K151812.
AVIVO Mobile Patient Management (MPM) System
K153160 · Medtronic, Inc. · Mar 2016
Passport Series Patient Monitors (Including Passport 8, Passport 12)
K153448 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2016
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
K152902 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2016
Panorama Patient Monitoring Network
K150082 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2015
V Series Monitoring System (including V12 and V21 Monitors)
K150352 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2015
Infinity CentralStation Wide
K151860 · Draeger Medical Systems, Inc. · Sep 2015