# K080495: Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Mar 24, 2008 after 31 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (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.
18 later devices descend from it; 5 cite it directly.
0 of 42 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
- K082280: Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital Signs Monitor (2008), 11 descendants of its own
- 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

## Recalls of this device
- Jul 13, 2018 · Class II · Z-2895-2018: 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

## 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/K080495
Methodology: https://510kreport.com/methodology