# K090483: Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns VM Series Patient Monitors

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Mar 20, 2009 after 23 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K941811 (1994). 23 ancestors in all.
14 later devices descend from it; 6 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052707: M3046B Compact Portable Patient Monitors, Philips Medical Systems (2005) Summary page 1.

## Most influential descendants
- K101067: Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068 (2010), 7 descendants of its own
- K120132: Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs Monitor (2012), 6 descendants of its own
- K103652: Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and Suresigns VM8 (2011), 6 descendants of its own
- K123900: Suresigns VM4, Suresigns VM6, Suresigns VM8 (2013), 5 descendants of its own
- K133961: Suresigns VS3, Suresigns VS4 (2014), 3 descendants of its own

## Recalls of this device
- May 19, 2020 · Class II · Z-2337-2020: Philips has identified a Philips SureSigns VM1 monitor in the possession of a clinical user that was not intended for commercial distribution and for which Philips does not have records regarding its 
- Jul 13, 2018 · Class II · Z-2896-2018: 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
- Jun 10, 2011 · Not classified · Z-2584-2011: Speakers on the SureSigns Patient Monitors and Vital Signs, failure may be identified by the display of a Speaker Malfunc message in the alarm message area or an AUDIO FAILED message in the main scree
- Oct 30, 2009 · Not classified · Z-0372-2010: Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker
- Oct 30, 2009 · Not classified · Z-0374-2010: Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker

## Indications for use
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.

Source page: https://510kreport.com/device/K090483
Methodology: https://510kreport.com/methodology