510(k) · Cleared
ClearedIsirona Magellan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isirona, LLC · MSX System, Network And Communication, Physiological Monitors
Cleared on Nov 20, 2013 as substantially equivalent to K102974 (Philips Medical Systems, 2011) after a 250-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Nov 20, 2013
- Review
- 250 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K962827 (1997). 8 ancestors in all, the oldest K945277 (1995). No later device cites it as a predicate yet.
- Root · 6 generations backK962827 Alarm Display Unit/Pager-Lan System (Adu)Marquette Electronics, Inc. · 1997
- 5 generations backK971868 Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
- 4 generations backK973527 Cardio-Pager SystemData Critical Corp. · 1998
- 3 generations backK992749 Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000
- 2 generations backK062278 Spacelabs Medical Clinical Event Interface, Model 91847Spacelabs Medical, Inc. · 2006
- 1 generation backK102974 Intellisphere Event Managment System Rel. 10.00Philips Medical Systems · 2011
- This deviceK130707 Isirona MagellanIsirona, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962827 | Alarm Display Unit/Pager-Lan System (Adu) | Marquette Electronics, Inc. | 1997 | — |
| −5 | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | 1997 | — |
| −4 | K973527 | Cardio-Pager System | Data Critical Corp. | 1998 | — |
| −3 | K992749 | Ultraview Waveform Pager System, Model 91841 | Spacelabs Medical, Inc. | 2000 | — |
| −2 | K062278 | Spacelabs Medical Clinical Event Interface, Model 91847 | Spacelabs Medical, Inc. | 2006 | — |
| −1 | K102974 | Intellisphere Event Managment System Rel. 10.00 | Philips Medical Systems | 2011 | — |
| 0 (this device) | K130707 | Isirona Magellan | Isirona, LLC | 2013 | — |
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 |
|---|---|---|---|
| * | K102974 | Intellisphere Event Managment System Rel. 10.00Summary page 1…Predicale Predicate Equivalent Devices: 51 0(k) Number Maniu/ac hirer /Model iSirona Magellan K 102974 Philips Medical Systems/ Philips Emergin Event… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- None of the 8 ancestors has a recall.
- 3 other devices also cite its predicate K102974.
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. 2013, 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 iSirona Magellan software solution provides healthcare professionals with supplemental information about patient alarms and other medical-related events. The product can route all or subsets of this information to selective. remote devices such as centralized computer stations and mobile communication devices. Receipt of alarm messages or events by the centralized computer stations and/or mobile communication devices is not confirmed and delivery to…
Read the full statement (105 words)
The iSirona Magellan software solution provides healthcare professionals with supplemental information about patient alarms and other medical-related events. The product can route all or subsets of this information to selective. remote devices such as centralized computer stations and mobile communication devices. Receipt of alarm messages or events by the centralized computer stations and/or mobile communication devices 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 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/K130707 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130707: Isirona Magellan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130707
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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