# K252389: Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)

- Pathway: 510(k) (Traditional)
- Applicant: Smwmed, Inc.
- Decided: Apr 23, 2026 after 266 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 K950944 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231289: S-Patch Ex Wearable ECG Patch, Wellysis Corp. (2023) Summary page 5.
- K171410: ePatch, Braemar Manufacturing, LLC (2018) Summary page 5.

## Indications for use
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, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. It is intended for use by patients 18 years or older.

Source page: https://510kreport.com/device/K252389
Methodology: https://510kreport.com/methodology