# K090027: Blood Pressure Monitor, ZSBP-003/004/005/006/007/008 and ZSBP-102/103/104/105/106/107

- Pathway: 510(k) (Special)
- Applicant: Zen Strong Medical Technology Co., Ltd.
- Decided: Feb 2, 2009 after 28 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: 5 generations back to K903134 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070473: Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XX, Zen Strong Medical Technology Co., Ltd. (2007) Summary page 2.

## Indications for use
ZSBP-003/004/005/006/007/008 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the patient of the age over 18 years old. ZSBP-102/103/104/105/106/107 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the patient of the age over 18 years old. All measurement values can be read out and keep memory on the LCD panel for home care use.

Source page: https://510kreport.com/device/K090027
Methodology: https://510kreport.com/methodology