# K151520: Oscar 2

- Pathway: 510(k) (Abbreviated)
- Applicant: Suntech Medical, Inc.
- Decided: Feb 19, 2016 after 259 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K903134 (1991). 40 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003004: Oscar 2, Model 222, Suntech Medical Instruments, Inc. (2000) Summary page 4.
- K122129: Sphygmocor Xcel, Atcor Medical (2012) Summary page 4.
- K140928: ABPM7100, I.E.M. GmbH (2014) Summary page 4.
- K133989: Ambulo 2400 Ambulatory Blood Pressure Monitoring System, Mortara Instrument, Inc. (2014) Summary page 4.

## Most influential descendants
- K210139: Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 (2021), 1 descendant of its own
- K251581: Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (2026), 0 descendants of its own
- K251591: Holter ECG and ABP system (HolterABP) (2026), 0 descendants of its own

## Recalls of this device
- Apr 20, 2020 · Class II · Z-2429-2020: The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg.
- Dec 11, 2019 · Class II · Z-0810-2020: The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalled because of a user safety issue when rechargeable batteries are misused in the product.

## Indications for use
The Oscar 2, Model 250 system is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to be used with AccuWin Pro, a PC-based computer program for the recording and displaying of up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult and pediatric (> 3yrs.) patient's systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnoses. Optionally, The Model 250 will provide a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively through the use of a brachial cuff. It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits (excludes pediatric subjects). BlueTooth, wireless connectivity will be offered as an option.

Source page: https://510kreport.com/device/K151520
Methodology: https://510kreport.com/methodology