# K040229: A&D Medical Lifesource Digital Blood Pressure Monitors, Model UB-328

- Pathway: 510(k) (Special)
- Applicant: A&D Engineering, Inc.
- Decided: Mar 19, 2004 after 46 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 K002115 (2000). 2 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002115: A&D Medical Lifesource UB-401PC & UB-401 Digital Blood Pressure Monitors, A&D Engineering, Inc. (2000)
- K012472: A & D Medical Lifesource UA-781, UA781PC, & UA-781T Digital Blood Pressure Monitors, A&D Engineering, Inc. (2002) Summary page 1.

## Most influential descendants
- K042967: A&D Medical Lifesource Digital Blood Pressure Monitors, Models UB-511 & UB-512 (2004), 16 descendants of its own
- K130564: Full Automatic (Nibp) Blood Pressure Monitor (2013), 6 descendants of its own
- K151281: AGE Automatic Wrist Blood Pressure Monitor (2015), 3 descendants of its own
- K130563: Full Automatic (Nibp) Blood Pressure Monitor (2013), 3 descendants of its own
- K193628: AGE Automatic Wrist Blood Pressure Monitor (2020), 2 descendants of its own

## Indications for use
Measure blood pressure (systolic and diastolic) and pulse rate.

Source page: https://510kreport.com/device/K040229
Methodology: https://510kreport.com/methodology