# K152659: V10

- Pathway: 510(k) (Traditional)
- Applicant: Mediana Co., Ltd.
- Decided: Aug 25, 2016 after 343 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962603 (1997). 107 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051375: Vital Signs Monitor, Mediana Co., Ltd. (2005) Summary page 4.
- K100225: Pulse Oximeter Model P10, Mediana Co., Ltd. (2011) Summary page 4.
- K142865: Nellcor Bedside SpO2 Patient Monitoring System, Covidien, LLC (2015). Our reading of the summary gave K142825, FDA’s number for Zmachine (Consolidated Research of Richmond, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Covidien LLC. Pulse Oximeters, Model Nellcor Bedside SpO2 Patient…”.
- K102426: Carescape Model V100 Vital Signs Monitor, Ge Medical Systems Information Technologies (2010) Summary page 4.
- K060649: Genius 2 Infrared Tympanic Electronic Thermometer, Model 303000, Tyco Healthcare Group LP (2006) Summary page 4.

## Most influential descendants
- K170497: V10 (2017), 1 descendant of its own
- K200434: V20, V20a, AVSM3 SNF (2020), 0 descendants of its own

## Indications for use
The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients 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 V10 is suitable for continuous operation. 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 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/K152659
Methodology: https://510kreport.com/methodology