# K210758: Q Patch

- Pathway: 510(k) (Traditional)
- Applicant: Medicalgorithmics S.A.
- Decided: Jun 2, 2022 after 444 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- 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 K950944 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 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 5.

## Most influential descendants
- K252839: ZywieZ3 Sensor & Adhesive (2026), 0 descendants of its own

## Indications for use
The Medicalgorithmics’ Q Patch is intended to be used by patients who have a demonstrated need for extended cardiac monitoring and patients with symptoms that may be due to cardiac arrhythmias such as, dizziness, lightheadedness, shortness of breath, palpitations, dyspnea (shortness of breath), anxiety, syncope of unknown etiology in which arrhythmias are suspected or need to be excluded. It is indicated for use on adult patients. The sensor records single ECG channel for up to 15 days and can be used on patients with implanted pacemakers but is not intended to record pacemaker activity.

Source page: https://510kreport.com/device/K210758
Methodology: https://510kreport.com/methodology