510(k) · Cleared
Recalled · Class II · 2024Philips Hemodynamic Application R1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederlands B.V. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Sep 7, 2018 as substantially equivalent to K101571 (Witt Biomedical Corp, 2010) after a 113-day review. Its family tree reaches back 6 generations to 1991. It has been recalled 2 times.
- Decided
- Sep 7, 2018
- Review
- 113 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K910772 (1991). 35 ancestors in all, the oldest K862740 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 5 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 2 generations backK020440 NewcorSiemens Medical Systems, Inc. · 2002 · Recalled
- 1 generation backK101571 Xper Information Management and Flex Cardio Physiomonitoring SystemsWitt Biomedical Corp · 2010 · Recalled
- This deviceK181311 Philips Hemodynamic Application R1.0Philips Medical Systems Nederlands B.V. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −5 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −2 | K020440 | Newcor | Siemens Medical Systems, Inc. | 2002 | 10 |
| −1 | K101571 | Xper Information Management and Flex Cardio Physiomonitoring Systems | Witt Biomedical Corp | 2010 | 8 |
| 0 (this device) | K181311 | Philips Hemodynamic Application R1.0 | Philips Medical Systems Nederlands B.V. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101571 | Xper Information Management and Flex Cardio Physiomonitoring SystemsSummary page 4…transferred to Invivo, a division of Philips Medical Systems 510(k) Clearance: K101571 (October 26, 2010) Classification Name: Cardiac monitor (including cardiotachometer and… | 2010 |
| † | K133323 | Volcano Ifr Modality | 2014 |
| † | K150441 | Volcano iFR Modality, iFR Scout feature | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 2, 2024 | Class II | Z-1926-2024 | Component design/selection | Potential for pressure wave data synchronization from two devices may not be correct. |
| Feb 22, 2022 | Class II | Z-1041-2022 | Under Investigation by firm | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 7.1 years on median.
- 10 of the 35 ancestors have a recall of any class.
- 1 other device also cites its predicate K101571.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The Philips Hemodynamic Application is intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment. The software may be used to display and/or analyze surface Electrocardiogram (ECG), Respiration, Invasive Blood Pressure (IBP), Pulse Oximetry (SpO2), End Tidal CO2 (ETCO2), Fractional Flow Reserve (FFR), Instant Wave-Free Ratio (iFR), Non-Invasive Blood Pressure (NIBP)…
Read the full statement (177 words)
The Philips Hemodynamic Application is intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment.
The software may be used to display and/or analyze surface Electrocardiogram (ECG), Respiration, Invasive Blood Pressure (IBP), Pulse Oximetry (SpO2), End Tidal CO2 (ETCO2), Fractional Flow Reserve (FFR), Instant Wave-Free Ratio (iFR), Non-Invasive Blood Pressure (NIBP), surface body Temperature and thermal Cardiac Output.
The software is intended for use with other devices, such as physiological monitoring systems, information management systems, image acquisition and other medical devices.
Use of the software in combination with physiological monitoring system is not intended to be used where unattended patient monitoring is desired, or in situations where arrhythmia detection is required.
The software in combination with an information management system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet.
The software is indicated for use in the following areas: (interventional) cardiology, electrophysiology and radiology.
The Philips Hemodynamic Application is indicated for use for all human patients of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181311: Philips Hemodynamic Application R1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181311
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026