# K060077: RTT Digital Wrist Blood Pressure Monitor, Model RTW-8010A

- Pathway: 510(k) (Traditional)
- Applicant: Real Tone Technology Corp.
- Decided: Mar 8, 2006 after 57 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
RTT Digital Blood Pressure Monitor Model RTW-8010A is indicated for nonivasive measurement of systolic and diastolic blood pressure and determination of pusise rate from user's wrist.

Source page: https://510kreport.com/device/K060077
Methodology: https://510kreport.com/methodology