# K251591: Holter ECG and ABP system (HolterABP)

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Feb 9, 2026 after 262 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K903134 (1991). 102 ancestors in all.
No later device cites it as a predicate yet.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151787: Holter System, Edan Instruments, Inc. (2016) Summary page 5.
- K210139: Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09, Edan Instruments, Inc. (2021) Summary page 5.

## Indications for use
The Holter ECG and ABP system is intended to acquire, analyze, display, edit and generate report of ambulatory ECG, ambulatory blood pressure and combined Holter ECG and ABP data. The analysis results are offered to doctors on an advisory basis only. Data acquired may be used for the following indications: · Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. · Evaluation of patients for ST segment changes. · Evaluation of drug response in patients taking anti-arrhythmic medications. · Evaluation of patients with pacemakers. The ambulatory blood pressure function is intended for use in patients over 12 years of age from data collected from an FDA cleared ambulatory blood pressure cuff. The ECG Analysis function is intended for use in adults and pediatric, but arrhythmia detection is intended for use in patients over 12 years of age. The Holter ECG and ABP system is intended to be used only in hospital and healthcare facilities by physicians or trained healthcare professionals.

Source page: https://510kreport.com/device/K251591
Methodology: https://510kreport.com/methodology