# K050697: Model DS-1901 Digital Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Seimitsu Sokki Co., Ltd.
- Decided: Mar 25, 2005 after 7 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.
77 later devices descend from it; 2 cite it directly.
0 of 80 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.

## Most influential descendants
- K071596: Potable Air Massager Putifino, Model AM-7 (2008), 55 descendants of its own
- K092435: Verseo Air Pressure Massager (2010), 54 descendants of its own
- K122154: Powerplay Muscle Massager (2012), 53 descendants of its own
- K160608: NormaTec Pulse and NormaTec Pulse Pro (2016), 51 descendants of its own
- K182668: Rapid Reboot Compression Therapy System (2018), 38 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 know hypertension in a home care environment as an adjunct to medical management.

Source page: https://510kreport.com/device/K050697
Methodology: https://510kreport.com/methodology