510(k) · Cleared
Recalled · Class II · 2024CareEvent inclusive of the CareEvent Mobile Application accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · MSX System, Network And Communication, Physiological Monitors
Cleared on Jun 24, 2016 as substantially equivalent to K142935 (Philips Medical Systems, 2015) after a 60-day review. Its family tree reaches back 7 generations to 1997. It has been recalled 3 times.
- Decided
- Jun 24, 2016
- Review
- 60 days
- Class
- Class II
- Product code
- MSX
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 7 generations to K962827 (1997). 9 ancestors in all, the oldest K945277 (1995). No later device cites it as a predicate yet.
- Root · 7 generations backK962827 Alarm Display Unit/Pager-Lan System (Adu)Marquette Electronics, Inc. · 1997
- 6 generations backK971868 Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
- 5 generations backK973527 Cardio-Pager SystemData Critical Corp. · 1998
- 4 generations backK992749 Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000
- 3 generations backK062278 Spacelabs Medical Clinical Event Interface, Model 91847Spacelabs Medical, Inc. · 2006
- 2 generations backK102974 Intellisphere Event Managment System Rel. 10.00Philips Medical Systems · 2011
- 1 generation backK142935 CareEventPhilips Medical Systems · 2015
- This deviceK161164 CareEvent inclusive of the CareEvent Mobile Application accessoryPhilips Medical Systems · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962827 | Alarm Display Unit/Pager-Lan System (Adu) | Marquette Electronics, Inc. | 1997 | — |
| −6 | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | 1997 | — |
| −5 | K973527 | Cardio-Pager System | Data Critical Corp. | 1998 | — |
| −4 | K992749 | Ultraview Waveform Pager System, Model 91841 | Spacelabs Medical, Inc. | 2000 | — |
| −3 | K062278 | Spacelabs Medical Clinical Event Interface, Model 91847 | Spacelabs Medical, Inc. | 2006 | — |
| −2 | K102974 | Intellisphere Event Managment System Rel. 10.00 | Philips Medical Systems | 2011 | — |
| −1 | K142935 | CareEvent | Philips Medical Systems | 2015 | — |
| 0 (this device) | K161164 | CareEvent inclusive of the CareEvent Mobile Application accessory | Philips Medical Systems | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2006 | 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 MSX? 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 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 |
|---|---|---|---|
| * | K142935 | CareEventSummary page 4…6310, I OUG Medical Device Data System III. Predicate device information Trade name: CareEvent Manufacturer: Philips Medical Systems 510(k) clearance: K142935 Classification name Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Device class: Class I… | 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 |
|---|---|---|---|---|
| Feb 28, 2024 | Class II | Z-1387-2024 | Under Investigation by firm | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode. |
| Nov 28, 2023 | Class II | Z-0731-2024 | Software design | Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition. |
| Nov 28, 2023 | Class II | Z-0732-2024 | Software design | Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
The intended use of Philips CareEvent is to deliver supplemental medical device data associated with physiological alarms, technical alarms, clinical notifications, nurse call alarms and informational messages to a healthcare professional’s end device. The user may receive visual or audible notifications, and/or other message notification types based on the communicator in use. Philips CareEvent is a component of a distributed alarming system. It does…
Read the full statement (173 words)
The intended use of Philips CareEvent is to deliver supplemental medical device data associated with physiological alarms, technical alarms, clinical notifications, nurse call alarms and informational messages to a healthcare professional’s end device. The user may receive visual or audible notifications, and/or other message notification types based on the communicator in use.
Philips CareEvent is a component of a distributed alarming system. It does not generate the alarm, alter the behavior of the alarm-generating system, replace the alarming system that generates the alarms, nor is it intended to provide real-time information, therefore the device producing the alarm or event remains the primary notification system. Philips CareEvent provides confirmed delivery features when it is used with the Philips CareEvent mobile application on Philips-approved devices. The Philips CareEvent mobile application either communicates alarm information that is sent from the Philips CareEvent server, or the user is notified that communication is not possible. Receipt of alarm messages or events by all other external devices is not confirmed and delivery to the end device is not guaranteed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161164: CareEvent inclusive of the CareEvent Mobile Application accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161164
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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