510(k) Report

FDA applicant

RhythMedix, LLC

Mt. Laurel, NJ3 decisions2014–20260 recalls

FDA records 3 decisions for RhythMedix, LLC (Mt. Laurel, NJ) from 2014 to 2026: 3 510(k) clearances. Most are in product codes QYX (Outpatient Cardiac Telemetry) and DXH (Transmitters And Receivers…). Its devices cite 5 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided RhythMedix, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2014: 12024: 12026 (partial year): 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — RhythMedix, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like RhythMedix, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QYXOutpatient Cardiac Telemetry2decisions
  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K141813Rhythmstar SystemRhythMedix, LLC · 20144cite it
  • K233584RhythmStar SystemRhythMedix, LLC · 20241cites it

What has FDA decided for it lately?

  • K250793RhythmStar System (SL)RhythMedix, LLC · 2026
  • K233584RhythmStar SystemRhythMedix, LLC · 2024
  • K141813Rhythmstar SystemRhythMedix, LLC · 2014

All 3 as RhythMedix, LLC →