# K230184: Holter ECG and ABP System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Sep 25, 2023 after 245 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: 6 generations back to K943862 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111096: Vasomedical-Biox Combined 12 Channel Ambulatory Ecg and Blood Pressure Recorder Model 2302, Vasomedical-Biox Ambulatory, Vasomedical, Inc. (2011) Summary page 5.

## Indications for use
The SA-20 Series recorder combines ambulatory ECG Holter and BP monitor. It is intended to acquire, store and display ambulatory ECG signals from adult and pediatric patient. It is capable of measuring systolic and diastolic blood pressures of adults and pediatrics (> 12 years) over a preprogrammed period of time. These measurements are displayed and stored in the recorder. It is intended to be used by trained personnel under the direction of doctors.

Source page: https://510kreport.com/device/K230184
Methodology: https://510kreport.com/methodology