# K200434: V20, V20a, AVSM3 SNF

- Pathway: 510(k) (Traditional)
- Applicant: Mediana Co., Ltd.
- Decided: Oct 9, 2020 after 228 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- 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: 15 generations back to K962603 (1997). 155 ancestors in all.
No later device cites it as a predicate yet.
3 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170497: V10, Mediana Co., Ltd. (2017) Summary page 4.
- K141518: Nellcor Bedside Respiratory Patient Monitoring System, Covidien (2015) Summary page 4.
- K183687: LifeWindow LW8 Lite, Digicare Biomedical Technology, Inc. (2019) Summary page 4.
- K003313: Filac Fas Temp Electronic Thermometer, The Kendall Company (2001) Summary page 4.
- K011291: Temporalscanner Thermometer, Sensortouch, Exergen Corp. (2001) Summary page 4.

## Recalls of this device
- May 17, 2021 · Class II · Z-2096-2021: In some cases the equipment fails to power up and/or key or button unresponsive or not working.

## Indications for use
The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR) and temperature (TEMP) in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement. Note: Hospital use typically includes such as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital-type facilities include ambulance, physician office-based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub-acute care centers. Note: The medically skilled and trained user can be clinicians like doctors and nurses who know how to take and interpret a patient’s vital signs. These clinicians must take direct responsibility for the patient’s life. This can include care-givers or medically trained interpreters who are authorized under the appropriate clinical facility procedures to support patient care. Any inappropriate setting, especially the alarm limit or alarm notification settings, can lead to a hazardous situation that injures the patient, harms the patient, or threatens the patient’s life. This equipment should only be operated by trained users who can adjust the settings of the vital signs monitor.

Source page: https://510kreport.com/device/K200434
Methodology: https://510kreport.com/methodology