# K973318: Mobimed System, (Pegasus and Polaris)

- Pathway: 510(k) (Traditional)
- Applicant: Ortivus Us, Inc.
- Decided: Feb 19, 1998 after 168 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K912189 (1992). 1 ancestor in all.
16 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912189: Likepak 11 Cardiac Monit/Lifenet RS100 Rec Station, Physio-Control Corp. (1992) Summary page 1.

## Most influential descendants
- K033410: Tempus 2000 Patient Monitor, Model 00-0002 (2004), 15 descendants of its own
- K082718: Tempusic Patient Monitor (2008), 14 descendants of its own
- K113105: Tempusic Patient Monitor (2011), 8 descendants of its own
- K152124: Tempus IC2 (2015), 7 descendants of its own
- K152645: Dictum Health (2016), 6 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K973318
Methodology: https://510kreport.com/methodology