Cleared Abbreviated

K181311 - Philips Hemodynamic Application R1.0

K181311 is the FDA 510(k) clearance for Philips Hemodynamic Application R1.0 by Philips Medical Systems Nederlands B.V.. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Abbreviated 510(k) pathway after a 113-day FDA review.

K181311 · Philips Medical Systems Nederlands B.V. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 2018
Decision
113d
Days
Class 2
Risk

K181311 is an FDA 510(k) clearance for the Philips Hemodynamic Application R1.0. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Philips Medical Systems Nederlands B.V. (Best Noord-Brabant, NL). The FDA issued a Cleared decision on September 7, 2018 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Philips Medical Systems Nederlands B.V. devices

Submission Details

510(k) Number K181311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2018
Decision Date September 07, 2018
Days to Decision 113 days
Submission Type Abbreviated
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
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

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