Cleared Traditional

K151812 - PATIENT MONITORS VARIOUS MODELS

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

K151812 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 198
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
IM60/IM70 PATIENT MONITOR
K131971 · Edan Instruments, Inc. · Mar 2014