# K123472: Cimva Universal

- Pathway: 510(k) (Traditional)
- Applicant: Therapeutic Monitoring Systems (Tms), Inc.
- Decided: Mar 5, 2013 after 112 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- 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
Longest line of descent: 27 generations back to K941811 (1994). 168 ancestors in all.
No later device cites it as a predicate yet.
0 of 169 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103646: Intellivue MX40 Patient Monitor, Phillips Medical Systems (2011) Summary page 1.

## Indications for use
CIMVA Universal is indicated for analyzing patterns of variation of physiological parameters (heart rate and respiratory rate) derived from the output of third party monitoring systems. CIMVA Universal is not designed for vital signs monitoring or self-monitoring of patients.

Source page: https://510kreport.com/device/K123472
Methodology: https://510kreport.com/methodology