510(k) · Cleared
ClearedHOTWIRE™ RF Guidewire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atraverse Medical · DXF Catheter, Septostomy
Cleared on May 1, 2024 as substantially equivalent to K150709 (Baylis Medical Company, Inc., 2015) after a 30-day review. Its family tree reaches back 3 generations to 2002. 2 later devices descend from it.
- Decided
- May 1, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- DXF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011727 (2002). 5 ancestors in all, the oldest K990284 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK011727 Transseptal Needle/TrocarThomas Medical Products, Inc. · 2002 · Recalled
- 2 generations backK073326 NRG Transseptal NeedleBaylis Medical Co., Inc. · 2008 · Recalled
- 1 generation backK150709 ProTrack RF Anchor WireBaylis Medical Company, Inc. · 2015 · Recalled
- This deviceK240900 HOTWIRE™ RF GuidewireAtraverse Medical · 2024
- Descendant · cites it directly · 1 of its ownK252419 Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK260292 Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011727 | Transseptal Needle/Trocar | Thomas Medical Products, Inc. | 2002 | 1 |
| −2 | K073326 | NRG Transseptal Needle | Baylis Medical Co., Inc. | 2008 | 1 |
| −1 | K150709 | ProTrack RF Anchor Wire | Baylis Medical Company, Inc. | 2015 | 1 |
| 0 (this device) | K240900 | HOTWIRE™ RF Guidewire | Atraverse Medical | 2024 | — |
| +1 | K252419 | Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX) | Atraverse Medical, Inc. | 2025 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K150709 | ProTrack RF Anchor WireSummary page 5…Class II Submission Type: Traditional 510(k) Regulation Number: 21 C.F.R. 870.5175 PREDICATE DEVICE [807.92(a)(3)] ProTrack RF Anchor Wire (K150709) DEVICE DESCRIPTION [807.92(a)(4)] The HOTWIRETM is a sterile, single-use guidewire device that delivers radiofrequency (RF) po… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252419 | Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX) | 2025 | 1 |
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 22 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K252419 (Atraverse Medical, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K150709.
How does its category compare?
All DXF devicesDXF Catheter, Septostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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/K240900 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240900: HOTWIRE™ RF Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240900
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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