# K051546: Bpcalibrator MC3000/MC3100

- Pathway: 510(k) (Traditional)
- Applicant: Healthstats International Pte., Ltd.
- Decided: Jun 24, 2005 after 11 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 K982481 (1998). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982481: A&D Medical UA-767PC Digital Blood Pressure Monitor, A&D Engineering, Inc. (1998) Summary page 1.

## Most influential descendants
- K101002: A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200 (2010), 2 descendants of its own
- K131788: Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application Software (2014), 0 descendants of its own
- K121266: Cardioscope (2012), 0 descendants of its own

## Indications for use
The BPCalibrator TM MC3000/MC3100 is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and-pulse rate. The device is intended for use at home or in doctor's office settings on patients who are eighteen (18) years and older and who do not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. The arm circumference range shall be between 8.3 inches (21 cm) and 16.5 inches (42 cm). The BPCalibrator TM MC3000 has a communication port that enables blood pressure and pulse rate readings to be transmitted to other electronic devices designed to communicate with it. Blood pressure and pulse rate readings obtained using the device are intended for use by qualified healthcare personnel as an aid to diagnosis and treatment.

Source page: https://510kreport.com/device/K051546
Methodology: https://510kreport.com/methodology