# K092785: Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software, 2301

- Pathway: 510(k) (Traditional)
- Applicant: Vasomedical, Inc.
- Decided: Apr 2, 2010 after 204 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: 4 generations back to K943862 (1995). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003004: Oscar 2, Model 222, Suntech Medical Instruments, Inc. (2000) Summary page 1.
- K083820: Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C, Vasomedical, Inc. (2009) Summary page 1.

## Most influential descendants
- K111096: Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure Recorder Model 2302, Vasomedical-Biox Ambulatory (2011), 1 descendant of its own
- K231104: ABPMpro (2023), 0 descendants of its own
- K230184: Holter ECG and ABP System (2023), 0 descendants of its own

## Indications for use
Vasomedical-Biox Combined Ambulatory EGG and Blood Pressure Recorder is a Non-Invasive oscillometric device intended to acquire Ambulatory 3 Channel EGG signals and non-invasive Blood Pressure signals from the upper body surfaces. Cardiac rhythm is acquired via 3 Channel ECG signals. The Recorders are intended for adults and children Who are over the age of six years. Vasomedical-Biox Ambulatory EGG CB Series Analysis System Software allows transfer of EGG and Blood Pressure data from the Recorder to a Windows based PC-based computer program via a removable and large capacity storage card (SD) for the purpose of creating reports and printouts. The Software does not perform diagnostics. Physicians carry out diagnostic evaluations of this data. The system is only for measurement, recording and display. It makes no diagnosis.

Source page: https://510kreport.com/device/K092785
Methodology: https://510kreport.com/methodology