510(k) · Cleared
ClearedHOTWIRE™ System RF Generator and Footswitch (optional accessory)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atraverse Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 12, 2025 as substantially equivalent to K232809 (Cross Vascular, Inc., 2023) after a 41-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Aug 12, 2025
- Review
- 41 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013904 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK013904 BMC Radio Frequency Perforation Generator, Models RFP-100-115 and…Baylis Medical Co., Inc. · 2002
- 2 generations backK122278 Baylis Medical Company Radiofrequency Perforation GeneratorBaylis Medical Company, Inc. · 2012
- 1 generation backK232809 Cross Vascular RF Generator and Footswitch (optional accessory)Cross Vascular, Inc. · 2023
- This deviceK252083 HOTWIRE™ System RF Generator and Footswitch (optional accessory)Atraverse Medical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013904 | BMC Radio Frequency Perforation Generator, Models RFP-100-115 and RFP-100-230 | Baylis Medical Co., Inc. | 2002 | — |
| −2 | K122278 | Baylis Medical Company Radiofrequency Perforation Generator | Baylis Medical Company, Inc. | 2012 | — |
| −1 | K232809 | Cross Vascular RF Generator and Footswitch (optional accessory) | Cross Vascular, Inc. | 2023 | — |
| 0 (this device) | K252083 | HOTWIRE™ System RF Generator and Footswitch (optional accessory) | Atraverse Medical, Inc. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K232809 | Cross Vascular RF Generator and Footswitch (optional accessory)Summary page 5…tion Class II Device Panel: General & Plastic Surgery PREDICATE DEVICE [807.92(a)(3)] Cross Vascular RF Generator and Footswitch (optional accessory) (K232809) REFERENCE DEVICE Baylis Medical Company Radiofrequency Perforation Generator, Model RFP-100A and optional footswitch (Model: RF… | 2023 |
| † | K122278 | Baylis Medical Company Radiofrequency Perforation Generator | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 10.7 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The HOTWIRE System RF Generator and Footswitch (optional accessory) is to be used with separately cleared RF puncture devices in cardiovascular transseptal access procedures to create an atrial septal defect.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252083 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252083: HOTWIRE™ System RF Generator and Footswitch (optional accessory).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252083
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026