510(k) Report

FDA applicant

Rhythmlink International, LLC

Columbia, SC18 decisions2002–20212 recalls

FDA records 18 decisions for Rhythmlink International, LLC (Columbia, SC) from 2002 to 2021: 18 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and GXZ (Electrode, Needle). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 6 of them its own earlier devices. 2 recalls are linked to its devices.

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

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

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

FDA decisions per year

1in 2021

2008: 12009: 22011: 22012: 22013: 22014: 12017: 12019: 22020: 12021: 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2015

2012: 12015: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Rhythmlink International, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • GXYElectrode, Cutaneous6decisions
  • GXZElectrode, Needle5decisions
  • IKTElectrode, Needle, Diagnostic Electromyograph3decisions
  • ETNStimulator, Nerve2decisions
  • PDQNeurosurgical Nerve Locator1decision
  • FMFSyringe, Piston1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 105 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 116 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 26 times; 6 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.

  • K022914Rhythmlink International Subdermal Needle ElectrodesRhythmlink International, LLC · 20028cite it
  • K061148Rhythmlink Disc ElectrodesRhythmlink International, LLC · 20066cite it
  • K052188Cutaneous ElectrodeRhythmlink International, LLC · 20053cite it
  • K072736Rhythmlink International Monopolar Stimulating InstrumentRhythmlink International, LLC · 20082cite it
  • K130287MR Conditional Cup Electrode, MR Conditional Webb ElectrodeRhythmlink International, LLC · 20132cite it
  • K132138Rhythmlink Disposable Concentric Stimulating ProbeRhythmlink International, LLC · 20141cites it

What has FDA decided for it lately?

  • K203079MR Conditional Sticky Pad ElectrodeRhythmlink International, LLC · 2021
  • K200984Guardian Needle ElectrodeRhythmlink International, LLC · 2020
  • K191225EEG Electrode TemplateRhythmlink International, LLC · 2019
  • K190801PressOn Electrode HeadsetRhythmlink International, LLC · 2019
  • K172503MR Conditional Cup Electrode, MR Conditional Webb ElectrodeRhythmlink International, LLC · 2017
  • K132138Rhythmlink Disposable Concentric Stimulating ProbeRhythmlink International, LLC · 2014
  • K130220MR Conditional Presson ElectrodeRhythmlink International, LLC · 2013
  • K130287MR Conditional Cup Electrode, MR Conditional Webb ElectrodeRhythmlink International, LLC · 2013

All 18 as Rhythmlink International, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K072736Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink…May 4, 2015Class II
  • K101700Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw…Mar 22, 2012Class II