Rhythmstar System

Q: When was Rhythmstar System cleared by the FDA?

Rhythmstar System (K141813) received a 510(k) decision of Substantially Equivalent on August 5, 2014, 29 days after the submission was received.

Q: What is the product code of K141813?

The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.

FDA 510(k) K141813 · RhythMedix, LLC

Substantially Equivalent

510(k) numberK141813

Submission

Device name: Rhythmstar System
Applicant: RhythMedix, LLC
Minneapolis, MN, US
Received: July 7, 2014
Decision date: August 5, 2014
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

Official FDA 510(k) record

Device classification

Product code: DXH – Transmitters And Receivers, Electrocardiograph, Telephone
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2920
Specialty: Cardiovascular

Other 510(k)s with product code DXH

510(k)	Device	Applicant	Decision
K250233	PreemptiveAI Clinical SDKDXH · Traditional	Measure Labs, Inc. (Dba Preemptiveai, Inc.)	02/13/2026SE
K250258	HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemDXH · Traditional	Heartbeam, Inc.	12/08/2025SE
K243438	MEMO Patch M (MPT-E08R-UNC01)DXH · Traditional	Huinno Co., Ltd.	12/05/2025SE
K243981	Hexoskin Medical System (7100-00016)DXH · Traditional	Carre Technologies, Inc.	11/18/2025SE
K243003	VitalSigns 1-Lead Holter (VSH101)DXH · Traditional	VitalSigns Technology Co., Ltd.	06/17/2025SE
K233521	QT ECG (QTERD100)DXH · Special	QT Medical, Inc.	12/06/2023SE
K222842	V-Patch Cardiac MonitorDXH · Traditional	Shandong Corecare Technology Limited	10/20/2022SE
K220795	QT ECGDXH · Traditional	QT Medical, Inc.	09/26/2022SE
K213357	Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorDXH · Traditional	Verily Life Sciences, LLC	07/19/2022SE
K220350	KardiaMobile 6LDXH · Traditional	AliveCor, Inc.	05/25/2022SE

More from AliveCor, Inc.

510(k)	Device	Decision
K250793	RhythmStar System (SL)QYX · Traditional	04/21/2026SE
K233584	RhythmStar SystemQYX · Traditional	07/08/2024SE

Questions and answers

When was Rhythmstar System cleared by the FDA?

Rhythmstar System (K141813) received a 510(k) decision of Substantially Equivalent on August 5, 2014, 29 days after the submission was received.

What is the product code of K141813?

The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.