Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rhythmlink International, LLC — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
174 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203079 | MR Conditional Sticky Pad Electrode | Rhythmlink International, LLC | 2021-02-09 | 119 | 0 |
| K200984 | Guardian Needle Electrode | Rhythmlink International, LLC | 2020-05-27 | 43 | 0 |
| K191225 | EEG Electrode Template | Rhythmlink International, LLC | 2019-08-05 | 90 | 0 |
| K190801 | PressOn Electrode Headset | Rhythmlink International, LLC | 2019-07-10 | 103 | 0 |
| K172503 | MR Conditional Cup Electrode, MR Conditional Webb Electrode | Rhythmlink International, LLC | 2017-12-01 | 105 | 0 |
| K132138 | RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE | Rhythmlink International, LLC | 2014-04-11 | 274 | 0 |
| K130220 | MR CONDITIONAL PRESSON ELECTRODE | Rhythmlink International, LLC | 2013-07-22 | 174 | 0 |
| K130287 | MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE | Rhythmlink International, LLC | 2013-05-30 | 114 | 0 |
| K121347 | PRESSON ELECTRODE | Rhythmlink International, LLC | 2012-07-12 | 72 | 1 |
| K120342 | EMG RECORDING ELECTRODE ASSEMBLY | Rhythmlink International, LLC | 2012-06-22 | 140 | 0 |
| K112435 | RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT | Rhythmlink International, LLC | 2011-09-22 | 29 | 0 |
| K103200 | PROPEP DELIVERY DEVICE | Rhythmlink International, LLC | 2011-04-12 | 162 | 0 |
| K091055 | RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D03903225 | Rhythmlink International, LLC | 2009-06-23 | 71 | 0 |
| K091056 | RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN260322 | Rhythmlink International, LLC | 2009-06-23 | 71 | 0 |
| K072736 | RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT | Rhythmlink International, LLC | 2008-01-22 | 117 | 1 |
| K061148 | RHYTHMLINK DISC ELECTRODES | Rhythmlink International, LLC | 2006-05-10 | 15 | 0 |
| K052188 | CUTANEOUS ELECTRODE | Rhythmlink International, LLC | 2005-08-23 | 12 | 0 |
| K022914 | RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES | Rhythmlink International, LLC | 2002-12-20 | 108 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda