# K052727: Rossmax Non-Invasive Blood Pressure Monitors, Models S380, K350

- Pathway: 510(k) (Traditional)
- Applicant: Rossmax International, Ltd.
- Decided: Dec 16, 2005 after 78 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
S380, K350 are non-invasive blood pressure monitors that are used for measuring systolic, diastolic, and pulse on the wrist, the wrist circumference 13.5-22cm for adult individual in a home environment.

Source page: https://510kreport.com/device/K052727
Methodology: https://510kreport.com/methodology