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RhythmStar RS-10002V

by RhythMedix, LLC

RhythmStar RS-10002V is an electrocardiography telemetric monitoring system (FDA Class II; FDA product code DXH, Transmitters And Receivers, Electrocardiograph, Telephone) made by RhythMedix, LLC, cleared under FDA 510(k) K141813 on 5 Aug 2014 and listed in FDA GUDID since 1 Feb 2019 (UDI-DI 00868282000213), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K141813

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00868282000213 UDI-DI Date1 Feb 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141813 Date5 Aug 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141813 decided 5 Aug 2014 Active
  • FDA GUDID UDI-DI 00868282000213 listed 1 Feb 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141813
  2. Listed FDA GUDID 00868282000213

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
RhythmStar
Generic name
Electrocardiography telemetric monitoring system
Model / reference
RS-10002V
Primary DI / UDI-DI
00868282000213
510(k) Number
FDA product code
DXH
GMDN term
Electrocardiography telemetric monitoring system
Device class
Class II
Regulation number
870.2920
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocardiography telemetric monitoring system

Cleared under the same submission (K141813)

Similar devices

Other devices filed under FDA product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone).

Other devices from RhythMedix, LLC

See all devices from RhythMedix, LLC →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)