# K053006: Rossmax Digital Sphygmomanometer Mandaus II

- Pathway: 510(k) (Traditional)
- Applicant: Rossmax Internationl, Ltd.
- Decided: Feb 3, 2006 after 100 days
- Product code: DXQ (Blood Pressure Cuff)
- Device class: 2
- Regulation: 21 CFR 870.1120
- 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
The Rossmax Digital Sphygmomanometer MANDAUS IL is a non-invasive medical device intended to measure the systolic, diastolic blood pressure for adults, using the auscultatory method by detecting Korotkoff sound. This device will be used by trained medical and health care personnel or trained general users.

Source page: https://510kreport.com/device/K053006
Methodology: https://510kreport.com/methodology