# K133810: VC150 Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Innokas Yhtyma
- Decided: Oct 30, 2014 after 318 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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: 14 generations back to K962603 (1997). 104 ancestors in all.
3 later devices descend from it; 2 cite it directly.
3 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102426: Carescape Model V100 Vital Signs Monitor, Ge Medical Systems Information Technologies (2010) Summary page 5.
- K101680: Welch Allyn Spot Vital Signs Lxi Model 45000 Series, Welch Allyn, Inc. (2010) Summary page 5.
- K110028: Masimo Radical Y Pulse CO-Oximeter, Masimo Corporation (2011) Summary page 6.
- K121806: Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System with Respiration Rate Software, Covidien (2012) Summary page 6.

## Most influential descendants
- K213490: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P (2022), 2 descendants of its own
- K242562: Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (2025), 0 descendants of its own
- K233810: Portrait VSM (2024), 0 descendants of its own

## Recalls of this device
- Jul 27, 2016 · Class II · Z-2604-2016: A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.
- Oct 22, 2015 · Class II · Z-0264-2016: Monitor may shut down unintentionally without restarting.
- Dec 3, 2014 · Class II · Z-1022-2015: If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to monitoring mode, the monitor does not issue visual and audible alarms.

## Indications for use
The VC150 is intended to monitor a single patient’s vital signs at the site of care or during intra-hospital transport. The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, diastolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients. The optional GE TruSignal pulse oximetry and accessories are indicated for continuous noninvasive monitoring of functional oxygen saturation (SpO2) and pulse rate, including monitoring during conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients. The optional Masimo Rainbow SET® Pulse CO-oximetry and accessories are indicated for the continuous noninvasive monitoring of: • functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, during both no motion and motion conditions, and for patients who are well or poorly perfused (low perfusion) for adult, pediatric and neonatal patients, • carboxyhemoglobin saturation (SpCO) for adult and pediatric patients, • methemoglobin saturation (SpMet) for adult, pediatric and neonatal patients, • total hemoglobin concentration (SpHb) for adult and pediatric patients, and/or • respiratory rate (RRa) for adult and pediatric patients. The optional Nellcor™ oximetry and accessories are indicated for the continuous, noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused. The optional Oximax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs. The optional Nellcor™ Respiration Rate parameter is intended for the continuous noninvasive monitoring of respiration rate in adult patients who are well perfused during non-motion conditions. The optional Welch Allyn SureTemp Plus electronic thermometer is intended to measure oral, axillary, and rectal temperature of adult and pediatric patients. The optional Exergen TemporalScanner thermometer is intended for the intermittent measurement of human body temperature of patients of all ages. A wireless network connection is provided to transmit clinical data into various hospital information systems. An optional remote alarm cable connection is intended to complement visual and audible alarms and not replace the need for the presence of a caregiver. The portable device is designed for use in hospitals and hospital-type facilities. The VC150 can also be used in satellite areas or alternate care settings. “Portable” refers to the ability of the VC150 to be easily moved by the caregiver, such as on a roll stand. The VC150 is not intended to be used for continuous monitoring during patient transport.

Source page: https://510kreport.com/device/K133810
Methodology: https://510kreport.com/methodology