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Philips Hemodynamic Application R1.0

by Philips Medical Systems Nederlands B.V.

510(k) K181311

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181311↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Abbreviated NumberK181311 Date7 Sep 2018ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1926-2024 FDA Class II initiated 2 May 2024

    Potential for pressure wave data synchronization from two devices may not be correct.

    • Terminated Z-1041-2022 FDA Class II initiated 22 Feb 2022

    When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure applied will be higher than 150 mmHg and the deflation pressure will be higher than 5 mmHg. An applied cuff inflation pressure higher than 150mmHg or a deflation pressure higher than 5 could lead to bruising, mmHg nerve damage or bone deformity for a neonate.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MWI
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Philips Hemodynamic Application R1.0 is a software-based medical device designed for the analysis and monitoring of hemodynamic parameters. It falls under the category of cardiovascular diagnostic software, enabling clinicians to assess cardiac function and circulatory dynamics through continuous or intermittent data acquisition and interpretation.

This application is intended for use in clinical settings such as hospitals and intensive care units, where it interfaces with compatible hemodynamic monitoring systems. Supplied as a software update or standalone application, it operates on compliant computing platforms and requires no sterility considerations as it is non-invasive. Authorized under FDA 510(k) clearance and MDR compliance, the device adheres to regulatory standards for cardiovascular diagnostic software, ensuring reliability and safety in hemodynamic assessments.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical environments is the Philips Hemodynamic Application R1.0 designed for, and how does it integrate with existing systems?

    The Philips Hemodynamic Application R1.0 is specifically designed for use in clinical settings like hospitals and intensive care units, where continuous or intermittent monitoring of hemodynamic parameters is critical. It interfaces with compatible hemodynamic monitoring systems to analyze cardiac function and circulatory dynamics. Since it is software-based, it operates on compliant computing platforms and does not require physical integration with patient-facing hardware, making it adaptable to existing workflows where such systems are already in place.

  • Is the Philips Hemodynamic Application R1.0 a standalone application, or is it supplied as an update to existing systems, and how does this affect its use?

    The Philips Hemodynamic Application R1.0 is supplied either as a software update or as a standalone application, depending on the user’s existing infrastructure. This flexibility allows clinicians to adopt it incrementally—whether by upgrading an existing system or deploying it independently on compliant computing platforms. Since it is non-invasive and does not require sterility, its use is limited to data analysis and monitoring rather than direct patient interaction, ensuring ease of integration without additional hardware constraints.

  • What regulatory pathways does the Philips Hemodynamic Application R1.0 follow, and what does this mean for its reliability and safety?

    The Philips Hemodynamic Application R1.0 is authorized under both FDA 510(k) clearance and MDR compliance, indicating it meets stringent regulatory standards for cardiovascular diagnostic software. The FDA’s abbreviated clearance (decision code: SESE) and the MDR framework ensure its reliability, safety, and equivalence to existing devices in the cardiovascular category, providing confidence in its clinical performance for assessing hemodynamic parameters.

  • Since this is a software-based device, does it require any special handling or storage conditions, and how does that differ from traditional medical devices?

    Unlike traditional medical devices, the Philips Hemodynamic Application R1.0 does not require sterility or physical storage precautions because it is non-invasive and operates digitally. However, it must be installed on compliant computing platforms that meet the manufacturer’s technical specifications to ensure proper functionality. Storage involves maintaining the software environment and system updates, rather than preserving physical components, which simplifies logistical handling in clinical settings.