# K070473: Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XX

- Pathway: 510(k) (Traditional)
- Applicant: Zen Strong Medical Technology Co., Ltd.
- Decided: May 23, 2007 after 92 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: 4 generations back to K903134 (1991). 6 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050249: HL168JP, Health & Life Co., Ltd. (2005) Summary page 2.
- K041411: Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-AP, Microlife Corp. (2004) Summary page 2.

## Most influential descendants
- K091553: Blood Pressure Monitor, Model WA400 for Wrist Type and Model AA300 for Upper Arm Type (2009), 2 descendants of its own
- K123839: WA Series: WA100; WA200; WD100; WE100, WF100; WB200 (2013), 0 descendants of its own
- K093739: Blood Pressure Monitor/ Models (2010), 0 descendants of its own
- K090027: Blood Pressure Monitor, ZSBP-003/004/005/006/007/008 and ZSBP-102/103/104/105/106/107 (2009), 0 descendants of its own

## Indications for use
ZSBP-001 and ZSBP-002 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-101 series of 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/K070473
Methodology: https://510kreport.com/methodology