# K984223: Blood Pressure Meter, Models CH-491, CH-481, CH-471

- Pathway: 510(k) (Special)
- Applicant: Citizen Watch Co., Ltd.
- Decided: Apr 28, 1999 after 154 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Citizen Watch Company, Ltd. CH-401 Blood Pressure Monitor: named in the summary without a submission number

## Indications for use
The Citizen CH-491, CH 481 and CH-471 digital arm sphygmomanometers (blood pressure meters) are intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse in adults and are intended to be sold over-the-counter and to health care professionals, and not primarily under the order or direction of a physician.

Source page: https://510kreport.com/device/K984223
Methodology: https://510kreport.com/methodology