# K053369: Medilog Darwin Holter Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Huntleigh Healthcare
- Decided: Dec 22, 2005 after 17 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: 1 generation back to K002544 (2000). 1 ancestor in all.
13 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002544: Medilog Excel 2 - Holter Management System, Oxford Instruments (2000) Summary page 1.

## Most influential descendants
- K083820: Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C (2009), 12 descendants of its own
- K101022: Pulmotrack 5050 Wholter, Model 5050 (2010), 6 descendants of its own
- K110525: Vitalograph Model 7100 - Vitalojak (2011), 5 descendants of its own
- K201077: Strados Remote Electronic Stethoscope Platform (RESP) (2020), 3 descendants of its own
- K092785: Combined Vasomedical-Biox Ambulatory Ecg & Blood Pressure Recorder & Analysis Software, 2301 (2010), 3 descendants of its own

## Indications for use
Medilog Darwin Holter Analysis is indicated for the replay and analysis of ECG data prerecorded on Medilog series ambulatory recorders. It is indicated for use in the analysis, display, editing and report generation of ambulatory ECG data as part of the assessment of cardiac rhythm disturbance and myocardial ischaemia. Typically it is intended for patients requiring analysis of 24 hour ambulatory ECG recordings as determined by a medical practitioner.

Source page: https://510kreport.com/device/K053369
Methodology: https://510kreport.com/methodology