# K103652: Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and Suresigns VM8

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systesms
- Decided: Jan 13, 2011 after 30 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: 8 generations back to K941811 (1994). 26 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 33 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 2.
- K080495: Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3, Philips Medical Systems (2008) Summary page 2.
- K090483: Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns VM Series Patient Monitors, Philips Medical Systems (2009) Summary page 2.
- K101067: Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068, Philips Medical Systems (2010) Summary page 2.

## Most influential descendants
- K123900: Suresigns VM4, Suresigns VM6, Suresigns VM8 (2013), 5 descendants of its own
- K133961: Suresigns VS3, Suresigns VS4 (2014), 3 descendants of its own
- K151761: SureSigns VS3, SureSigns VS4 (2015), 2 descendants of its own
- K163649: SureSigns VS3; SureSigns VS4 (2017), 1 descendant of its own
- K190624: EarlyVue VS30 (2019), 0 descendants of its own

## Indications for use
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: *ECG -Respiration *NBP *Sp02 *IBP *C02 *Temperature

Source page: https://510kreport.com/device/K103652
Methodology: https://510kreport.com/methodology