Rhythmlink International, LLC: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Rhythmlink International, LLC” (first 2002, latest 2021), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 104 days. Since 2017 the median was 103 days, against 149 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 106 |
| 2013 | 2 | 144 |
| 2014 | 1 | 274 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 105 |
| 2018 | 0 | — |
| 2019 | 2 | 96 |
| 2020 | 1 | 43 |
| 2021 | 1 | 119 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Rhythmlink International, LLC took a median 103 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 149 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 6 | 6 |
| GXZ | Electrode, Needle | 5 | 5 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 3 | 3 |
| ETN | Stimulator, Nerve | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| PDQ | Neurosurgical Nerve Locator | 1 | 1 |
Review panels
- Neurology (15)
- Ear, Nose and Throat (2)
- General Hospital (1)
Most recent Rhythmlink International, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203079 | MR Conditional Sticky Pad Electrode | GXY | 2021-02-09 | 119 |
| K200984 | Guardian Needle Electrode | GXZ | 2020-05-27 | 43 |
| K191225 | EEG Electrode Template | GXY | 2019-08-05 | 90 |
| K190801 | PressOn Electrode Headset | GXZ | 2019-07-10 | 103 |
| K172503 | MR Conditional Cup Electrode, MR Conditional Webb Electrode | GXY | 2017-12-01 | 105 |
| K132138 | RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE | PDQ | 2014-04-11 | 274 |
| K130220 | MR CONDITIONAL PRESSON ELECTRODE | GXZ | 2013-07-22 | 174 |
| K130287 | MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE | GXY | 2013-05-30 | 114 |
| K121347 | PRESSON ELECTRODE | GXZ | 2012-07-12 | 72 |
| K120342 | EMG RECORDING ELECTRODE ASSEMBLY | IKT | 2012-06-22 | 140 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Rhythmlink International, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Rhythmlink International, LLC?
FDA lists 18 510(k) clearances under the applicant name “Rhythmlink International, LLC” (first 2002, latest 2021), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rhythmlink International, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rhythmlink International, LLC is 104 days. Since 2017: 103 days, versus 149 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Rhythmlink International, LLC?
The most frequent FDA product codes under this applicant name are GXY (Electrode, Cutaneous, 6); GXZ (Electrode, Needle, 5); IKT (Electrode, Needle, Diagnostic Electromyograph, 3).
Next steps
- See all 18 Rhythmlink International, LLC clearances with predicates and recalls
- Run predicate analysis for product code GXY, Rhythmlink International, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.