# K071384: Modification to: Digital Blood Pressure Monitor, Model 1901

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Seimitsu Sokki Co., Ltd.
- Decided: Oct 9, 2007 after 145 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: 3 generations back to K850316 (1985). 3 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050697: Model DS-1901 Digital Blood Pressure Monitor, Nihon Seimitsu Sokki Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K080177: Wrist Blood Pressure Monitor, Model WS-1100/WS-1100PV (2008), 19 descendants of its own
- K092161: Full Automatic (Nibp) Blood Pressure Monitor, Model HL868BF (2009), 14 descendants of its own
- K093831: Fully Automatic (Nibp) Blood Pressure Monitor, Model HL868RT (2010), 12 descendants of its own
- K131121: Full Automatic (Nibp) Blood Pressure Monitor (2013), 9 descendants of its own
- K113238: Full Automatic (Nibp) Blood Pressue Monitor (2012), 9 descendants of its own

## Indications for use
The DS-1901 system is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adult patients, i.e., age 12 and above. The product is recommended for use by patients with labile blood pressure or known hypertension in a home care environment as an adjunct to medical management. The device displays irregular pulse rhythm indication when it is detected during measurement.

Source page: https://510kreport.com/device/K071384
Methodology: https://510kreport.com/methodology