# K013046: Cosmos System

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Aug 21, 2002 after 345 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K062095: Mcare 300 Vital Signs Monitor, Model 91220 (2006), 3 descendants of its own
- K100217: Lucon M-Series Patient Monitor, Models M20 and M30 (2010), 1 descendant of its own
- K112190: Patient Monitor (2011), 0 descendants of its own
- K082045: Modification to Mcare 300 Vital Signs Monitor, Model 91220 (2008), 0 descendants of its own
- K031124: Polaris 95000-a Bedside/Transport Monitor (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K013046
Methodology: https://510kreport.com/methodology