# K023078: Bptru Vital Signs Monitor, Model BPM-300, & Bptru Portable Automated Non-Invasive Blood Pressure and Temperature Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Vsm Medtech, Ltd.
- Decided: Mar 21, 2003 after 186 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 K951193 (1996). 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)
- K994423: Automated Non-Invasive Blood Pressure Monitor, Model BPM-100, Vsm Medtech, Ltd. (2000) Summary page 1.
- K002046: Modification to Automated Non-Invasive Blood Pressure Monitor, Model BPM-100, Vsm Technology, Inc. (2000)
- K012636: Bptru Automated Non-Invasive Blood Pressure Monitor, Model BPM-100, Vsm Technology, Inc. (2001)
- K951193: Clinical Vital Signs Monitor, Model #52STP-E1, Tycos Instruments, Inc. (1996) Summary page 1.

## Indications for use
The BpTRU Vital Signs Monitor: Measures systolic and diastolic blood pressure and pulse rate in subjects 3 years of age or older. Measures temperatures in subjects 3 years of age or older. Is intended for use in physicians’ offices, nursing units, and patient care areas of hospitals.

Source page: https://510kreport.com/device/K023078
Methodology: https://510kreport.com/methodology