# K010828: Digital Blood Pressure Monitors, Models TM-2655, TM-2655P, & TM-2655VP

- Pathway: 510(k) (Traditional)
- Applicant: A&D Engineering, Inc.
- Decided: Mar 29, 2001 after 9 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.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices 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.

## Most influential descendants
- K131064: Biospace (2013), 4 descendants of its own
- K200442: InBody (2020), 2 descendants of its own
- K151953: A&D Medical TM-2657 Family of Digital Blood Pressure Monitors (2016), 2 descendants of its own
- K221764: InBody Blood pressure monitor, Model BPBIO480KV (2022), 1 descendant of its own
- 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

## Indications for use
The A&D Medical LifeSource TM-2655, TM-2655P & TM-2655VP are designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).

Source page: https://510kreport.com/device/K010828
Methodology: https://510kreport.com/methodology