# K123900: Suresigns VM4, Suresigns VM6, Suresigns VM8

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Apr 18, 2013 after 121 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: 12 generations back to K962603 (1997). 65 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 71 devices in its family (counting itself) has 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.
- K080495: Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3, Philips Medical Systems (2008) Summary page 1.
- K090483: Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns VM Series Patient Monitors, Philips Medical Systems (2009) Summary page 1.
- K101067: Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068, Philips Medical Systems (2010) Summary page 1.
- K103652: Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and Suresigns VM8, Philips Medical Systesms (2011) Summary page 1.
- K094012: CAPNOSTREAM20 with MICROMEDICO2 Module, Oridion Capnography, Inc. (2010) Summary page 1.

## Most influential descendants
- 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
- K151812: Patient Monitors Various Models (2016), 0 descendants of its own

## Recalls of this device
- Mar 23, 2021 · Class II · Z-1326-2021: Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the input signal rate is over 300 bpm, the in
- 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. Standard and optional parameters include: ECG * Respiration * NBP * SpO2 * IBP * CO2 * Temperature

Source page: https://510kreport.com/device/K123900
Methodology: https://510kreport.com/methodology