# K060925: Acon Automatic Blood Pressure Monitor Kit,  Model OB11-111, W/AC Adapter, Model OB11-112

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: May 9, 2006 after 35 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 K930798 (1993). 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)
- K930798: Omron Oscillometric Digital Blood Pressure Monit., Omron Healthcare, Inc. (1993) Summary page 1.

## Indications for use
The ACON Automatic Blood Pressure Monitor is a fully automatic blood pressure monitor that measures systolic blood pressure (SYS), diastolic blood pressure (DIA) and pulse rate (P). It is intended to be sold over-the-counter for home use.

Source page: https://510kreport.com/device/K060925
Methodology: https://510kreport.com/methodology