# K013717: Brentwood Real Time ST and Arrhythmia Analysis Software Library

- Pathway: 510(k) (Traditional)
- Applicant: Brentwood Medical Technology Corp.
- Decided: Feb 6, 2002 after 90 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 K003621 (2000). 1 ancestor in all.
72 later devices descend from it; 2 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003621: ST/AR ST and Arrhythmia Software, Model Release D.0, Agilent Technologies, Inc. (2000) Summary page 1.

## Most influential descendants
- K043380: Monebo Automatic Arrhythmia Detection Software Library, Version 1 (2005), 71 descendants of its own
- K062282: Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0 (2007), 70 descendants of its own
- K091075: Zeus (Zio Ecg Utilization Service) System (2009), 32 descendants of its own
- K142681: ZEUS (ZIO ECG Utilization Service) System (2014), 31 descendants of its own
- K143513: ZIO SR ECG Monitoring Service (2015), 30 descendants of its own

## Indications for use
The intended user is a medical device manufacturer who will integrate the ST/AR Library into a computerized cardiac monitoring device. The manufacturer/integrator will ultimately identify the indications for use, depending on the nature of their device. The analysis capabilities of the ST/AR Library are indicated for monitoring and detecting the following from up to 12 body surface ECG leads for adult, pediatric, or neonatal patients: QRS detection ventricular ectopic beat detection (non-paced only) rhythm call analysis, including asystole, bigeminy, couplets, irregular heart rate, pause or missed beat, VEB/minute, run, trigeminy, triplets, ventricular tachycardia ST segment level measurement (adult patients only) ventricular fibrillation detection

Source page: https://510kreport.com/device/K013717
Methodology: https://510kreport.com/methodology