# K143513: ZIO SR ECG Monitoring Service

- Pathway: 510(k) (Traditional)
- Applicant: iRhythm Technologies, Inc.
- Decided: Jun 19, 2015 after 190 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 K963725 (1997). 26 ancestors in all.
30 later devices descend from it; 9 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142681: ZEUS (ZIO ECG Utilization Service) System, iRhythm Technologies, Inc. (2014) Summary page 5.
- K121319: Zio Patch, iRhythm Technologies, Inc. (2012) Summary page 5.
- K121628: Epi Mini Ecg Portable Health Monitoring System (Epi Mini), Epi Mobile Health Solutions (S) Pte, Ltd. (2013) Summary page 5.

## Most influential descendants
- K163512: Zio AT ECG Monitoring System (2017), 18 descendants of its own
- K181502: Zio AT ECG Monitoring System, ZEUS System (2018), 12 descendants of its own
- K210822: DeepRhythmAI (2022), 6 descendants of its own
- K190593: Zio XT ECG Monitoring System, Zio AT ECG Monitoring System (2019), 4 descendants of its own
- K241197: DeepRhythmAI (2024), 3 descendants of its own

## Indications for use
The ZIO® SR ECG Monitoring Service is intended to capture, analyze, and report symptomatic and/or continuous electrocardiogram (ECG) information for long-term monitoring (up to 14 days). It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.

Source page: https://510kreport.com/device/K143513
Methodology: https://510kreport.com/methodology