510(k) · Cleared
ClearedIntellisphere Event Managment System Rel. 10.00
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 Jan 4, 2011 as substantially equivalent to K062278 (Spacelabs Medical, Inc., 2006) and 1 other predicate after a 90-day review. Its family tree reaches back 5 generations to 1997. 5 later devices descend from it.
- Decided
- Jan 4, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K962827 (1997). 7 ancestors in all, the oldest K945277 (1995). 5 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK962827 Alarm Display Unit/Pager-Lan System (Adu)Marquette Electronics, Inc. · 1997
- 4 generations backK971868 Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
- 3 generations backK973527 Cardio-Pager SystemData Critical Corp. · 1998
- 2 generations backK992749 Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000
- 1 generation backK062278 Spacelabs Medical Clinical Event Interface, Model 91847Spacelabs Medical, Inc. · 2006
- This deviceK102974 Intellisphere Event Managment System Rel. 10.00Philips Medical Systems · 2011
- Descendant · cites it directly · 1 of its ownK142935 CareEventPhilips Medical Systems · 2015
- Descendant · 2 generations on · 0 of its ownK161164 CareEvent inclusive of the CareEvent Mobile Application accessoryPhilips Medical Systems · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK130707 Isirona MagellanIsirona, LLC · 2013
- Descendant · cites it directly · 0 of its ownK112650 Connexall Suite of Software ProductsConnexall USA, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK112047 Amcom Commtech MessengerAmcom Software,Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K142935CareEventPhilips Medical Systems · 2015 · cites it directly1descendant
- K161164CareEvent inclusive of the CareEvent Mobile Application accessoryPhilips Medical Systems · 2016 · 2 generations on0descendants
- K130707Isirona MagellanIsirona, LLC · 2013 · cites it directly0descendants
- K112650Connexall Suite of Software ProductsConnexall USA, Inc. · 2012 · cites it directly0descendants
- K112047Amcom Commtech MessengerAmcom Software,Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962827 | Alarm Display Unit/Pager-Lan System (Adu) | Marquette Electronics, Inc. | 1997 | — |
| −4 | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | 1997 | — |
| −3 | K973527 | Cardio-Pager System | Data Critical Corp. | 1998 | — |
| −2 | K992749 | Ultraview Waveform Pager System, Model 91841 | Spacelabs Medical, Inc. | 2000 | — |
| −1 | K062278 | Spacelabs Medical Clinical Event Interface, Model 91847 | Spacelabs Medical, Inc. | 2006 | — |
| 0 (this device) | K102974 | Intellisphere Event Managment System Rel. 10.00 | Philips Medical Systems | 2011 | — |
| +1 | K142935 | CareEvent | Philips Medical Systems | 2015 | — |
| +2 | K161164 | CareEvent inclusive of the CareEvent Mobile Application accessory | Philips Medical Systems | 2016 | 3 |
| +1 | K130707 | Isirona Magellan | Isirona, LLC | 2013 | — |
| +1 | K112650 | Connexall Suite of Software Products | Connexall USA, Inc. | 2012 | — |
| +1 | K112047 | Amcom Commtech Messenger | Amcom Software,Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K062278 | Spacelabs Medical Clinical Event Interface, Model 91847Summary page 1…follows: 3. The Philips Emergin Event Management product is substantially equivalent to previously cleared Spacelabs device marketed pursuant to K062278, and Masimo Patient Safety Net K(061932. 4. The introduction of a software only event management product. 5. The intend… | 2006 |
| * | K061932 | Bernoulli Management System (MS) SoftwareSummary page 1…Event Management product is substantially equivalent to previously cleared Spacelabs device marketed pursuant to K062278, and Masimo Patient Safety Net K(061932. 4. The introduction of a software only event management product. 5. The intended use is: The Philips Emergin E… | 2006 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K142935 (Philips Medical Systems, 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K062278.
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. 2011, 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 the Intellisphere Event Management product is to provide healthcare professionals with supplemental information about patient alarms, technical alarms, nurse call alarms and system information messages (events). The product can route all or subsets of this information to selective remote devices such as pagers, phones, or marquees. Receipt of alarm messages or events by the external device, is not confirmed and delivery to the end…
Read the full statement (110 words)
The intended use of the Intellisphere Event Management product is to provide healthcare professionals with supplemental information about patient alarms, technical alarms, nurse call alarms and system information messages (events). The product can route all or subsets of this information to selective remote devices such as pagers, phones, or marquees. Receipt of alarm messages or events by the external device, is not confirmed and delivery to the end device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product line is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102974 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102974: Intellisphere Event Managment System Rel. 10.00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102974
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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