510(k) · Cleared
ClearedMobimed System, (Pegasus and Polaris)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortivus Us, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Feb 19, 1998 as substantially equivalent to K912189 (Physio-Control Corp., 1992) after a 168-day review. Its family tree reaches back 1 generation to 1992. 16 later devices descend from it.
- Decided
- Feb 19, 1998
- Review
- 168 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912189 (1992). 16 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK912189 Likepak 11 Cardiac Monit/Lifenet RS100 Rec StationPhysio-Control Corp. · 1992
- This deviceK973318 Mobimed System, (Pegasus and Polaris)Ortivus Us, Inc. · 1998
- Descendant · cites it directly · 15 of its ownK033410 Tempus 2000 Patient Monitor, Model 00-0002Remote Diagnostic Technologies, Ltd. · 2004
- Descendant · 2 generations on · 14 of its ownK082718 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2008
- Descendant · 3 generations on · 8 of its ownK113105 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011
- Descendant · 4 generations on · 7 of its ownK152124 Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015
- Descendant · 5 generations on · 6 of its ownK152645 Dictum HealthDictum Health, Inc. · 2016
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K033410Tempus 2000 Patient Monitor, Model 00-0002Remote Diagnostic Technologies, Ltd. · 2004 · cites it directly15descendants
- K082718Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2008 · 2 generations on14descendants
- K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011 · 3 generations on8descendants
- K152124Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015 · 4 generations on7descendants
- K152645Dictum HealthDictum Health, Inc. · 2016 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912189 | Likepak 11 Cardiac Monit/Lifenet RS100 Rec Station | Physio-Control Corp. | 1992 | — |
| 0 (this device) | K973318 | Mobimed System, (Pegasus and Polaris) | Ortivus Us, Inc. | 1998 | — |
| +1 | K033410 | Tempus 2000 Patient Monitor, Model 00-0002 | Remote Diagnostic Technologies, Ltd. | 2004 | — |
| +2 | K082718 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2008 | — |
| +3 | K113105 | Tempusic Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2011 | — |
| +4 | K152124 | Tempus IC2 | Remote Diagnostics Technologies, Ltd. | 2015 | — |
| +5 | K152645 | Dictum Health | Dictum Health, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K912189 | Likepak 11 Cardiac Monit/Lifenet RS100 Rec StationSummary page 1…ivus believes the Mobimed™ System is substantially equivalent to the LifePak® Cardiac Monitor/LifeNet RS100 Receiving Station manufactured by Physio-Control Corporation (K912189) The SpO, module is the Nellcor MP204P, same as used in the NPB-75 made by Spegas (K964239) . Description of the Device The Mob… | 1992 |
| † | K964239 | Combination Oximeter/Carbon Dioxide Gas Analyzer | 1997 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033410 | Tempus 2000 Patient Monitor, Model 00-0002 | 2004 | 15 |
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?
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.
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 Ortivus AB Mobimed™ is a cardiac monitoring system consisting of a portable and stationary unit which communicate with each other using the Mobitex radio-based cellular telecommunications network. The cardiac data includes ECG, SpO,, NIBP, GCS, and patient information. The system is intended for use by trained personnel in emergency care, specifically emergency ambulance and pre-hospital care.
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/K973318 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973318: Mobimed System, (Pegasus and Polaris).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973318
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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