# K974192: Biosensor Holter Monitor System

- Pathway: 510(k) (Traditional)
- Applicant: Biosensor Corp.
- Decided: Mar 4, 1998 after 117 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K003940: 2010 Plus Holter for Windows (2001), 1 descendant of its own
- K142349: TM eCloud ECG Analysis System (2015), 0 descendants of its own

## Indications for use
The Biosensor Frequency Domain Heart Rate Variability , (FD HRV), analysis option is being incorporated into the Biosensor Holter Monitor System for quantification and graphical displays of heart rate changes over a specific monitoring period as an aid to other clinical diagnostic techniques. The FD HRV graph is modeled after the recommendations of the Task Force of the European Society of Cardiology (Circulation. 1996;93: 1042-1065). FD HRV is intended to provide HRV spectra for any selected time segment of 5 minutes of duration or longer, at the physician’s discretion. Precaution: - N Computerized ECG analysis should not replace diagnosis by a qualified physician. The physician should verify that the reported data is accurate before applying clinical conclusions. Since various neural, respiratory, and endocrine factors are known to affe.ct' heart rate variability, the significance of the data must be determined by a physician. FD HRV analysis may differ amang devices from different manufactyrers since methods and algorithms may vary. Caution should be used in applying conclusions drawn from studies with other devices. Validation data for FD HRV will be made available upon request.

Source page: https://510kreport.com/device/K974192
Methodology: https://510kreport.com/methodology