# K173065: A&D Medical Blood Pressure Monitors

- Pathway: 510(k) (Traditional)
- Applicant: A&D Company, Ltd.
- Decided: Apr 24, 2019 after 572 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: 1 generation back to K992808 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992808: A&D Medical TM-2430 and TM-2431 Ambulatory Blood Pressure, A&D Medical Div. (1999) Summary page 4.

## Indications for use
TM-2440 and TM-2441 blood pressure monitors are designed to monitor systolic and diastolic pressure, and pulse rate of adults who are twelve (12) years and older by using the oscillometric method. TM-2441 has four environmental functions to measure activity monitoring (3-axis accelerometer) , ambient temperature monitoring, barometric pressure monitoring, and waveform capability. These functions are not observed by patients form the device display and can only be used by the medical professionals.

Source page: https://510kreport.com/device/K173065
Methodology: https://510kreport.com/methodology