510(k) Report

FDA applicant

Rhythmia Medical, Inc.

Burlington, MA3 decisions2013–20151 recall

FDA records 3 decisions for Rhythmia Medical, Inc. (Burlington, MA) from 2013 to 2015: 3 510(k) clearances. Most are in product codes DRF (Catheter, Electrode Recording, Or Probe…) and DQK (Computer, Diagnostic, Programmable). Its devices cite 4 predicates, 1 of them its own earlier devices. 1 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 Rhythmia Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2013: 22015: 1
2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1
2013high 1 (2014) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Rhythmia Medical, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rhythmia Medical, Inc.’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?

  • DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2decisions
  • DQKComputer, Diagnostic, Programmable1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K130750Rhythmia Mapping SystemRhythmia Medical, Inc. · 20131cites it
  • K143481IntellaMap Orion High Resolution Mapping CatheterRhythmia Medical, Inc. · 20151cites it
  • K122461Rhythmia Mapping CatheterRhythmia Medical, Inc. · 20131cites it

What has FDA decided for it lately?

  • K143481IntellaMap Orion High Resolution Mapping CatheterRhythmia Medical, Inc. · 2015
  • K130750Rhythmia Mapping SystemRhythmia Medical, Inc. · 2013
  • K122461Rhythmia Mapping CatheterRhythmia Medical, Inc. · 20131 recall

All 3 as Rhythmia Medical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K122461IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog…Nov 20, 2014Class II