# K202456: M5 Recorder

- Pathway: 510(k) (Abbreviated)
- Applicant: Global Instrumentation, LLC
- Decided: Dec 29, 2020 after 124 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: 7 generations back to K963725 (1997). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163535: my Patch sl, Dms-Service, LLC (2017) Summary page 4.
- K143513: ZIO SR ECG Monitoring Service, iRhythm Technologies, Inc. (2015) Summary page 5.

## Indications for use
The M5 Recorder is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. The M5 Recorder is intended for use by adults and all pediatric subgroups ( weighing IO kg or more).

Source page: https://510kreport.com/device/K202456
Methodology: https://510kreport.com/methodology