# K151953: A&D Medical TM-2657 Family of Digital Blood Pressure Monitors

- Pathway: 510(k) (Traditional)
- Applicant: A&D Company, Ltd.
- Decided: Apr 13, 2016 after 273 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: 3 generations back to K982481 (1998). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043217: A&D Medical UA-767PBT Digital Blood Pressure Monitor, A&D Engineering, Inc. (2005) Summary page 4.
- K010828: Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VP, A&D Engineering, Inc. (2001) Summary page 4.

## Most influential descendants
- K251102: Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) (2025), 0 descendants of its own
- K200287: BP-BT Kiosk (2020), 0 descendants of its own

## Indications for use
TM-2657, TM-2657P, TM-2657PBT, and TM-2657PRS are designed to measure blood pressure (systolic and diastolic) and pulse rate in adult patients with arm circumference range between 7.1 inches (18.0 cm) to 13.8 inches (35.0 cm).

Source page: https://510kreport.com/device/K151953
Methodology: https://510kreport.com/methodology