# K133961: Suresigns VS3, Suresigns VS4

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Jun 26, 2014 after 184 days
- Product code: DSJ (Alarm, Blood-Pressure)
- Device class: 2
- Regulation: 21 CFR 870.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962603 (1997). 81 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 85 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120132: Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs Monitor, Philips Medical Systems (2012) Summary page 1.
- K123900: Suresigns VM4, Suresigns VM6, Suresigns VM8, Philips Medical Systems (2013) Summary page 1.
- K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter, Masimo Corporation (2010) Summary page 2.
- K011291: Temporalscanner Thermometer, Sensortouch, Exergen Corp. (2001) Summary page 2.
- K094012: CAPNOSTREAM20 with MICROMEDICO2 Module, Oridion Capnography, Inc. (2010) Summary page 2.

## Most influential descendants
- 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
The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility. The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

Source page: https://510kreport.com/device/K133961
Methodology: https://510kreport.com/methodology