# K051368: BR 102 Plus Blood Pressure Holter System

- Pathway: 510(k) (Traditional)
- Applicant: Schiller AG
- Decided: Aug 9, 2005 after 76 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: 1 generation back to K913844 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913844: Accutracker DX, Suntech Medical Instruments, Inc. (1992) Summary page 2.
- K003004: Oscar 2, Model 222, Suntech Medical Instruments, Inc. (2000) Summary page 2.

## Indications for use
The BR-102 plus is a non-invasive ambulatory blood pressure monitor. It uses auscultatoric and oscillometric signals to measure the blood pressure of human beings, or uses purely the oscillometric signals. Systolic, diastolic, mean arterial pressure and the heart rate are measured. The BR-102 plus is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult or adolescent patient's blood pressure over an extended period of time (up to 48h). The BR-102 plus can be used for patients of both sexes and all races. The BR-102 plus should not be used with neonates.

Source page: https://510kreport.com/device/K051368
Methodology: https://510kreport.com/methodology