# K994423: Automated Non-Invasive Blood Pressure Monitor, Model BPM-100

- Pathway: 510(k) (Traditional)
- Applicant: Vsm Medtech, Ltd.
- Decided: Mar 28, 2000 after 90 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K023078: Bptru Vital Signs Monitor, Model BPM-300, & Bptru Portable Automated Non-Invasive Blood Pressure and Temperature Monitor (2003), 0 descendants of its own
- K023055: Bptru Portable Automated Non-Invasive Blood Pressure Monitor, Model BPM-200 (2002), 0 descendants of its own

## Indications for use
The BPM-100: Measures systolic and diastolic blood pressure and pulse rate in adults greater than 18 years of age. Is intended for use in physicians’ offices, nursing units, and patient care areas of hospitals.

Source page: https://510kreport.com/device/K994423
Methodology: https://510kreport.com/methodology