510(k) · Cleared
ClearedHotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atraverse Medical · DXF Catheter, Septostomy
Cleared on Feb 27, 2026 as substantially equivalent to K252419 (Atraverse Medical, Inc., 2025) after a 29-day review. Its family tree reaches back 5 generations to 2002.
- Decided
- Feb 27, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- DXF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K011727 (2002). 7 ancestors in all, the oldest K990284 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK011727 Transseptal Needle/TrocarThomas Medical Products, Inc. · 2002 · Recalled
- 4 generations backK073326 NRG Transseptal NeedleBaylis Medical Co., Inc. · 2008 · Recalled
- 3 generations backK150709 ProTrack RF Anchor WireBaylis Medical Company, Inc. · 2015 · Recalled
- 2 generations backK240900 HOTWIRE™ RF GuidewireAtraverse Medical · 2024
- 1 generation backK252419 Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical, Inc. · 2025
- This deviceK260292 Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011727 | Transseptal Needle/Trocar | Thomas Medical Products, Inc. | 2002 | 1 |
| −4 | K073326 | NRG Transseptal Needle | Baylis Medical Co., Inc. | 2008 | 1 |
| −3 | K150709 | ProTrack RF Anchor Wire | Baylis Medical Company, Inc. | 2015 | 1 |
| −2 | K240900 | HOTWIRE™ RF Guidewire | Atraverse Medical | 2024 | — |
| −1 | K252419 | Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX) | Atraverse Medical, Inc. | 2025 | — |
| 0 (this device) | K260292 | Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX) | Atraverse Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 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 DXF? 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 DXF device
- #1 K242076 VersaCross™ RF Wirescore 14.9 · 3 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 |
|---|---|---|---|
| * | K252419 | Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Summary page 5…g this Special 510(k) Premarket Notification for the HOTWIRETM RF Guidewire. The HOTWIRETM RF Guidewire has previously been cleared under the Traditional 510(k) Program (K252419), in which Atraverse Medical, Inc. is the legal manufacturer. SUBMITTER [807.92(a)(1)] Atraverse Medical, Inc. 2611 S Coast Hwy… | 2025 |
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 24 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- 3 of the 7 ancestors have a recall of any class.
How does its category compare?
All DXF devicesDXF Catheter, Septostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DXF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXF
83in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXF
3in 2020
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DXF
682in 2025
MAUDE reports naming product code DXF, 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 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 0 | — | 1 | 13 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 36 |
| 2019 | 1 | — | 0 | 24 |
| 2020 | 0 | — | 3 (3) | 55 |
| 2021 | 1 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 70 |
| 2023 | 1 | — | 0 | 286 |
| 2024 | 4 | 83 | 0 | 368 |
| 2025 | 2 | — | 0 | 682 |
| 2026 | 3 | 30 | 0 | — |
What is it indicated for?
The HOTWIRE is indicated for creation of an atrial septal defect in the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260292: Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260292
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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