# K113083: Truly Automatic Arm Blood Pressure Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Truly Instrument Co., Ltd.
- Decided: Jan 19, 2012 after 93 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
Longest line of descent: 5 generations back to K903134 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091434: Truly Automatic Arm Blood Pressure MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M, Truly Instrument Co., Ltd. (2009) Summary page 1.

## Indications for use
Truly Automatic Arm Blood Pressure Monitor, Models DB33, DB81, DB82, DB83, DB8S, DB391, DB92, DB93 are a series device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices features include irregular pulse rhythm detection during measurement, and display a warning signal with the reading once the irregular heartbeat is detected.

Source page: https://510kreport.com/device/K113083
Methodology: https://510kreport.com/methodology