# K243650: Zio® monitor  (DFG0001)

- Pathway: 510(k) (Traditional)
- Applicant: iRhythm Technologies, Inc.
- Decided: Aug 15, 2025 after 262 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: 2 generations back to K121319 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202359: Zio Monitor, iRhythm Technologies, Inc. (2021) Summary page 6.

## Indications for use
The Zio monitor is a prescription-only, single-use, ECG monitor that continuously records data for up to 14 days. It is indicated for use on patients, 18 years and older, 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/K243650
Methodology: https://510kreport.com/methodology