# K012636: Bptru Automated Non-Invasive Blood Pressure Monitor, Model BPM-100

- Pathway: 510(k) (Traditional)
- Applicant: Vsm Technology, Inc.
- Decided: Oct 26, 2001 after 74 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 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
- K061073: Clever Check TD-3250 Blood Glucose and Blood Pressure Measurement System, Model TD-3250 (2006), 3 descendants of its own
- K062800: Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek TD-3217/ Clever Chek TD-3250 Blood Glucose Plus Blo (2007), 2 descendants of its own
- K092875: Echo TD-3227 Dual Blood Pressure/Blood Glucose Meter (2010), 0 descendants of its own
- K080014: Clever Chek TD-3250C Blood Glucose Plus Blood Pressure Monitoring System (2008), 0 descendants of its own
- K023078: Bptru Vital Signs Monitor, Model BPM-300, & Bptru Portable Automated Non-Invasive Blood Pressure and Temperature Monitor (2003), 0 descendants of its own

## Indications for use
The BpTRU: Measures systolic and diastolic blood pressure and pulse rate 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/K012636
Methodology: https://510kreport.com/methodology