# K233810: Portrait VSM

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Apr 25, 2024 after 147 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 35 generations back to K941811 (1994). 392 ancestors in all.
No later device cites it as a predicate yet.
7 of 393 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133810: VC150 Vital Signs Monitor, Innokas Yhtyma (2014) Summary page 7.
- K213490: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P, Ge Medical Systems Information Technologies, Inc. (2022) Summary page 7.
- K171888: Non-contact infrared body thermometer, Hetaida Technology Co., Ltd. (2018) Summary page 7.

## Recalls of this device
- Sep 26, 2025 · Class II · Z-0456-2026: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will 

## Indications for use
The Portrait VSM vital signs monitor 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 the 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 SET@ pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (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. The optional Nellcorm pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional 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 WelchAllyn@ SureTemp®Plus electronic thermometer is intended to measure one of 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. The optional HeTaiDa electronic infrared non-touch 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 Portrait VSM vital signs monitor can also be used in satellite areas or alternate care settings. The Portrait VSM vital signs monitor is intended for use under the direct supervision of a licensed health care practitioner. The Portrait VSM vital signs monitor is not intended for use during MRI. "Portable" refers to the ability of the Portrait VSM vital signs monitor to be easily moved by the caregiver, such as on a roll stand.

Source page: https://510kreport.com/device/K233810
Methodology: https://510kreport.com/methodology