# K111096: Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure Recorder Model 2302, Vasomedical-Biox Ambulatory

- Pathway: 510(k) (Special)
- Applicant: Vasomedical, Inc.
- Decided: Jun 24, 2011 after 65 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K943862 (1995). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092785: Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software, 2301, Vasomedical, Inc. (2010) Summary page 1.

## Most influential descendants
- K230184: Holter ECG and ABP System (2023), 0 descendants of its own

## Indications for use
Vasomedical-Biox Model 2302 Combined 12 Channel Ambulatory EGG and Blood Pressure Recorder isa Non-Invasive device intended to acquire Ambulatory 12 Channel EGG signals and non-invasive oscillometric Blood Pressure signals from the upper body surfaces. Cardiac rhythm is acquired via EGG signals. Vasomedical-Biox Model 1804 Ambulatory BP Recorder is a non-invasive device intended to acquire ambulatory non-invasive oscillometric Blood Pressure signals from the upper body surfaces. The Recorders are intended for adults and children who are over the age of six years. The Models 2302 and 1804 work with the CB Series ECG and ABP Analysis Software which has been previously cleared under (k)092785 "The Intended Use of the modified devices as described in its labeling, has not changed as a result of the modifications". The system is only for measurement, recording and display. It makes no diagnosis

Source page: https://510kreport.com/device/K111096
Methodology: https://510kreport.com/methodology