# K964153: Rossmax Automatic Wristwatch Blood Pressure Monitor, Model RM-4000

- Pathway: 510(k) (Traditional)
- Applicant: Rossmax International, Ltd.
- Decided: Jun 11, 1998 after 603 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 no predicate by number.

## Indications for use
To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between of 5.3 to 7.7 inches.

Source page: https://510kreport.com/device/K964153
Methodology: https://510kreport.com/methodology