# K070588: Philips Suresigns VSV (Vital Signs Viewer)

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Mar 20, 2007 after 19 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921014 (1992). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921014: Model M2350A and M2360A Wavevue Central Monitor, Hewlett-Packard Co. (1992) Summary page 1.

## Most influential descendants
- K131032: Philips Suresigns Central (2013), 1 descendant of its own
- K160951: Philips Efficia CMS200 Central Monitoring System (2016), 0 descendants of its own

## Recalls of this device
- Jul 13, 2018 · Class II · Z-2892-2018: Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3
- Oct 30, 2009 · Not classified · Z-0373-2010: Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker

## Indications for use
Indicated for central monitoring of multiple adult, pediatric, and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

Source page: https://510kreport.com/device/K070588
Methodology: https://510kreport.com/methodology