# K190624: EarlyVue VS30

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medizin Systeme Boeblingen GmbH
- Decided: Oct 27, 2019 after 230 days
- Product code: DSJ (Alarm, Blood-Pressure)
- Device class: 2
- Regulation: 21 CFR 870.1100
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K962603 (1997). 84 ancestors in all.
No later device cites it as a predicate yet.
1 of 85 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163649: SureSigns VS3; SureSigns VS4, Philips Medical Systems (2017) Summary page 5.
- K151761: SureSigns VS3, SureSigns VS4, Phillips Medical Systems (2015) Summary page 5.
- K133961: Suresigns VS3, Suresigns VS4, Philips Medical Systems (2014) Summary page 5.

## Recalls of this device
- Aug 31, 2023 · Class II · Z-2655-2023: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
- Aug 31, 2023 · Class II · Z-2654-2023: A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
- Mar 6, 2023 · Class II · Z-1645-2023: EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condi

## Indications for use
The EarlyVue VS30 is intended to measure, display, alarm and, record physiological information of adult, pediatric and neonatal patients in hospitals and in out-of-hospital patient care settings in which care is administered by a healthcare professional (such as clinics, outpatient surgery facilities, long-term care facilities, and physician offices). It is not intended for use in mobile settings such as ambulances and aircraft. Clinical users may use the monitor during patient transport within a healthcare facility. The intended use of measurement parameters for each patient type is shown in table below (Parameter (patient types)): Non-invasive BP--NBP (Adult, Pediatric, Neonatal); SpO2 --Masimo rainbow SET or Philips FAST (Adult, Pediatric, Neonatal); Pulse Rate --PR--derived from SpO2 or NBP (Adult, Pediatric, Neonatal); Temperature-Predictive, Temporal (Adult, Pediatric, Neonatal); end tidal CO2--etCO2 (Adult, Pediatric, Neonatal); Respiration Rate: airway respiration--awRR (Adult, Pediatric, Neonatal); Respiration Rate: acoustic respiration--RRa (Adult, Pediatric); Non-invasive Total Hemoglobin--SpHb (Adult, Pediatric) Contra-indications: Not for transport outside the healthcare facility. Not for use in home setting.

Source page: https://510kreport.com/device/K190624
Methodology: https://510kreport.com/methodology