510(k) · Cleared
ClearedCross Vascular RF Generator and Footswitch (optional accessory)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cross Vascular, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 12, 2023 as substantially equivalent to K122278 (Baylis Medical Company, Inc., 2012) after a 30-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Oct 12, 2023
- Review
- 30 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013904 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK013904 BMC Radio Frequency Perforation Generator, Models RFP-100-115 and…Baylis Medical Co., Inc. · 2002
- 1 generation backK122278 Baylis Medical Company Radiofrequency Perforation GeneratorBaylis Medical Company, Inc. · 2012
- This deviceK232809 Cross Vascular RF Generator and Footswitch (optional accessory)Cross Vascular, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK252083 HOTWIRE™ System RF Generator and Footswitch (optional accessory)Atraverse Medical, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K252083HOTWIRE™ System RF Generator and Footswitch (optional accessory)Atraverse Medical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013904 | BMC Radio Frequency Perforation Generator, Models RFP-100-115 and RFP-100-230 | Baylis Medical Co., Inc. | 2002 | — |
| −1 | K122278 | Baylis Medical Company Radiofrequency Perforation Generator | Baylis Medical Company, Inc. | 2012 | — |
| 0 (this device) | K232809 | Cross Vascular RF Generator and Footswitch (optional accessory) | Cross Vascular, Inc. | 2023 | — |
| +1 | K252083 | HOTWIRE™ System RF Generator and Footswitch (optional accessory) | Atraverse Medical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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 |
|---|---|---|---|
| * | K122278 | Baylis Medical Company Radiofrequency Perforation GeneratorSummary page 5…Boston Scientific Perforation Generator, Model RFP-100A [formerly Baylis Medical] K122278 and optional footswitch (Model: RFA-FS) 5.1 Device Description The Cross Vascular RF Generator (Figure 1) is a rechargeable bat… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252083 | HOTWIRE™ System RF Generator and Footswitch (optional accessory) | 2025 | 0 |
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 21 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252083 (Atraverse Medical, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K122278.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Cross Vascular RF Generator and Footswitch (optional accessory) are to be used with separately cleared RF puncture devices in cardiovascular transseptal access procedures to create an atrial septal defect.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232809 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232809: Cross Vascular RF Generator and Footswitch (optional accessory).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232809
Report an extraction error
Are you the manufacturer?
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