# K063814: BP-200 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Schiller AG
- Decided: Mar 7, 2007 after 75 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: 7 generations back to K910772 (1991). 22 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053209: Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System, Suntech Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K101619: Welch Allyn 1500 Patient Monitor (2010), 4 descendants of its own
- K133973: Tempus Pro with Enhanced Features (2014), 3 descendants of its own
- K170567: Tempus Pro Patient Monitor (2017), 2 descendants of its own
- K173768: Tempus Pro Patient Monitor (2018), 1 descendant of its own
- K152043: Diagnostic Station DS20 (2016), 1 descendant of its own

## Indications for use
The BP-200 plus is intended to be used as an adjunct to exercise stress testing devices. It is intended to measure and display diastolic and systolic blood pressure, heart rate, percentage of oxygen saturation in arterial blood (SpO2) and pulse rate in adult or adolescent patients during stress tests. The measurement cuff of the BP-200 plus in intended to be placed on the upper right arm of the patient. The BP-200 plus can be used for patients of both sexes and all races. The BP-200 plus should not be used with neonates.

Source page: https://510kreport.com/device/K063814
Methodology: https://510kreport.com/methodology