# K021029: ABP-2000 G-3

- Pathway: 510(k) (Traditional)
- Applicant: Biotrac, Inc.
- Decided: Apr 12, 2002 after 14 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: 3 generations back to K855127 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012647: Tonoport V, Par Medizintechnik GmbH (2001) Summary page 1.
- K003004: Oscar 2, Model 222, Suntech Medical Instruments, Inc. (2000) Summary page 1.
- K964235: Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp Control, Industrielle Entwicklung Medizintechnik Und Vertri (1999) Summary page 1.

## Indications for use
It is intended to be used as an aid or support for the initial diagnosis and subsequent treatment’s follow-up when it is necessary to measure a patient’s blood pressure over a determined period of time. The system does not make any diagnose, it only measures, stores and displays the information. The ABP-2000 G-3 (NIBP) monitor is only intended and designed: - for measuring the systolic, diastolic and mean blood pressure as well as the heart rate of human beings. - for recording during a predetermined period of time the above mentioned measurements (up to 250 measurements). - to be used along with the ABP-2000 G-3 software for programming as well as record keeping and display in a graphical or tabular report.

Source page: https://510kreport.com/device/K021029
Methodology: https://510kreport.com/methodology