# K954547: CH-502A & CH520B Digital Finger Sphygmomanometer

- Pathway: 510(k) (Traditional)
- Applicant: Citizen Watch Co., Ltd.
- Decided: Apr 1, 1997 after 550 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: 1 generation back to K894563 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894563: Omron Digital Blood Pressure Monitor Model HEM814F, Omron Electronics, Inc. (1990) Summary page 1.

## Indications for use
The Citizen CH-502A and CH-502B finger sphygmomanometers are intended to be used for the oscillometric measurement of systolic and diastolic blood pressure and pulse.

Source page: https://510kreport.com/device/K954547
Methodology: https://510kreport.com/methodology