# K061086: DM-3000 Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Seimitsu Sokki Co., Ltd.
- Decided: Aug 10, 2006 after 114 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: 2 generations back to K850316 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993890: Digital Blood Pressure Monitor, Model DS-181, Nihon Seimitsu Sokki Co., Ltd. (1999) Summary page 1.

## Indications for use
The DM-3000 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adolescents (age 12 to 21 years) adult patients, i.e., age 21 and above and is intended to be operated by physicians or under supervision of a physician.

Source page: https://510kreport.com/device/K061086
Methodology: https://510kreport.com/methodology