# Rhythmlink International, LLC

- Location (FDA's records): Columbia, SC
- FDA decisions: 18 (2002–2021): 18 510(k) clearances
- Product codes: GXY (6), GXZ (5), IKT (3), ETN (2), PDQ (1), FMF (1)
- 510(k) review time since 2016: median 105 days, against 116 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 17 (6 its own); citations of its devices by later devices: 26 (6 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Neuro Supplies, Inc.: 2 (https://510kreport.com/company/neuro-supplies)
- Cadwell Lab, Inc.: 1 (https://510kreport.com/company/cadwell-lab)
- Minrad, Inc.: 1 (https://510kreport.com/company/minrad)
- Persyst Development Corporation: 1 (https://510kreport.com/company/persyst-development)
- Jordan Neuroscience, Inc.: 1 (https://510kreport.com/company/jordan-neuroscience)
- Medtronic Xomed, Inc.: 1 (https://510kreport.com/company/medtronic-xomed)
- Ambu A/S: 1 (https://510kreport.com/company/ambu-a-s)
- Bio-Logic Systems Corp.: 1 (https://510kreport.com/company/bio-logic-systems)

## Firms that cite its devices most
- Nuvasive, Inc.: 4 (https://510kreport.com/company/nuvasive)
- Spes Medica Srl: 3 (https://510kreport.com/company/spes-medica)
- Isurgical: 1 (https://510kreport.com/company/isurgical)
- Natus Manufacturing Limited: 1 (https://510kreport.com/company/natus-manufacturing)
- Neuroinvent, Inc.: 1 (https://510kreport.com/company/neuroinvent)
- Persyst Development Corporation: 1 (https://510kreport.com/company/persyst-development)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Xian Friendship Electronics Co., Ltd.: 1 (https://510kreport.com/company/xian-friendship-electronics)

## Its most-cited devices
- K022914: Rhythmlink International Subdermal Needle Electrodes (2002), cited by 8
- K061148: Rhythmlink Disc Electrodes (2006), cited by 6
- K052188: Cutaneous Electrode (2005), cited by 3
- K072736: Rhythmlink International Monopolar Stimulating Instrument (2008), cited by 2
- K130287: MR Conditional Cup Electrode, MR Conditional Webb Electrode (2013), cited by 2
- K132138: Rhythmlink Disposable Concentric Stimulating Probe (2014), cited by 1

## Recent decisions
- K203079: MR Conditional Sticky Pad Electrode (Feb 9, 2021)
- K200984: Guardian Needle Electrode (May 27, 2020)
- K191225: EEG Electrode Template (Aug 5, 2019)
- K190801: PressOn Electrode Headset (Jul 10, 2019)
- K172503: MR Conditional Cup Electrode, MR Conditional Webb Electrode (Dec 1, 2017)
- K132138: Rhythmlink Disposable Concentric Stimulating Probe (Apr 11, 2014)
- K130220: MR Conditional Presson Electrode (Jul 22, 2013)
- K130287: MR Conditional Cup Electrode, MR Conditional Webb Electrode (May 30, 2013)

Source page: https://510kreport.com/company/rhythmlink-international