# K163649: SureSigns VS3; SureSigns VS4

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems
- Decided: Mar 31, 2017 after 98 days
- Product code: DSJ (Alarm, Blood-Pressure)
- Device class: 2
- Regulation: 21 CFR 870.1100
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K962603 (1997). 83 ancestors in all.
1 later device descends from it; 1 cites 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)
- K151761: SureSigns VS3, SureSigns VS4, Phillips Medical Systems (2015) Summary page 5.

## Most influential descendants
- K190624: EarlyVue VS30 (2019), 0 descendants of its own

## Recalls of this device
- Apr 19, 2019 · Class II · Z-1324-2019: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
- Apr 19, 2019 · Class II · Z-1319-2019: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
- Apr 19, 2019 · Class II · Z-1317-2019: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
- Apr 19, 2019 · Class II · Z-1318-2019: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
- Apr 19, 2019 · Class II · Z-1320-2019: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
- Apr 19, 2019 · Class II · Z-1323-2019: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
- Apr 19, 2019 · Class II · Z-1321-2019: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
- Apr 19, 2019 · Class II · Z-1322-2019: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
- Jul 13, 2018 · Class II · Z-2894-2018: 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
- Jul 13, 2018 · Class II · Z-2893-2018: 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
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 SureSignsVS3 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. Parameter (patient types): NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); Temperature (Adult, Pediatric, Neonatal) Contraindications: Not for transport outside the 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. Parameter (patient types): NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); Temperature (Adult, Pediatric, Neonatal); CO2 (Adult, Pediatric, Neonatal); RRa (Adult, Pediatric); SpHb (Adult, Pediatric) Contraindications: Not for transport outside the healthcare facility

Source page: https://510kreport.com/device/K163649
Methodology: https://510kreport.com/methodology