# K021225: Rossmax Automatic Blood Pressure Monitor, Model Cardiocare 1000I

- Pathway: 510(k) (Special)
- Applicant: Rossmax International, Ltd.
- Decided: May 22, 2002 after 34 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K070209: FB-100U Series Digital Blood Pressure Monitor (2007), 0 descendants of its own
- K043352: Gocanning GLS-700 E-Pulse Analysis Monitor (2005), 0 descendants of its own

## Indications for use
The blood pressure monitor is used to measure systolic, diastolic, and pulse rates in adult consumers with arm circumference between 22 cm to 32 cm (8.7” to 12.6”)

Source page: https://510kreport.com/device/K021225
Methodology: https://510kreport.com/methodology