# K202359: Zio Monitor

- Pathway: 510(k) (Traditional)
- Applicant: iRhythm Technologies, Inc.
- Decided: May 21, 2021 after 275 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: 1 generation back to K121319 (2012). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121319: Zio Patch, iRhythm Technologies, Inc. (2012) Summary page 5.

## Most influential descendants
- K250882: Sansa Hsat (2025), 0 descendants of its own
- K243650: Zio® monitor  (DFG0001) (2025), 0 descendants of its own

## Indications for use
The Zio Monitor is a prescription-only, single-patient-use, ECG monitor that continuously records data for up to 14 days. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue or anxiety.

Source page: https://510kreport.com/device/K202359
Methodology: https://510kreport.com/methodology