510(k) · Cleared
Recalled · Class II · 2025ProTrack RF Anchor Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Company, Inc. · DXF Catheter, Septostomy
Cleared on Jun 17, 2015 as substantially equivalent to K990284 (Baylis Medical Co., Inc., 2001) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 2002. 7 later devices descend from it. It has been recalled once.
- Decided
- Jun 17, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- DXF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011727 (2002). 4 ancestors in all, the oldest K990284 (2001). 7 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK011727 Transseptal Needle/TrocarThomas Medical Products, Inc. · 2002 · Recalled
- 1 generation backK073326 NRG Transseptal NeedleBaylis Medical Co., Inc. · 2008 · Recalled
- This deviceK150709 ProTrack RF Anchor WireBaylis Medical Company, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK242076 VersaCross™ RF WireBaylis Medical Company · 2024
- Descendant · cites it directly · 2 of its ownK240900 HOTWIRE™ RF GuidewireAtraverse Medical · 2024
- Descendant · 2 generations on · 1 of its ownK252419 Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK261745 LightningWire Transseptal Puncture System (TPS)ElectroWire Medical · 2026
- Descendant · 2 generations on · 0 of its ownK260839 Protaryx Transseptal Puncture Device (PTX2-001)Protaryx Medical, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K242076VersaCross™ RF WireBaylis Medical Company · 2024 · cites it directly2descendants
- K240900HOTWIRE™ RF GuidewireAtraverse Medical · 2024 · cites it directly2descendants
- K252419Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical, Inc. · 2025 · 2 generations on1descendant
- K261745LightningWire Transseptal Puncture System (TPS)ElectroWire Medical · 2026 · cites it directly0descendants
- K260839Protaryx Transseptal Puncture Device (PTX2-001)Protaryx Medical, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011727 | Transseptal Needle/Trocar | Thomas Medical Products, Inc. | 2002 | 1 |
| −1 | K073326 | NRG Transseptal Needle | Baylis Medical Co., Inc. | 2008 | 1 |
| 0 (this device) | K150709 | ProTrack RF Anchor Wire | Baylis Medical Company, Inc. | 2015 | — |
| +1 | K242076 | VersaCross™ RF Wire | Baylis Medical Company | 2024 | — |
| +1 | K240900 | HOTWIRE™ RF Guidewire | Atraverse Medical | 2024 | — |
| +2 | K252419 | Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX) | Atraverse Medical, Inc. | 2025 | — |
| +1 | K261745 | LightningWire Transseptal Puncture System (TPS) | ElectroWire Medical | 2026 | — |
| +2 | K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | 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 |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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? (2)
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 |
|---|---|---|---|
| * | K990284 | Baylis Medical RF Septostomy Generator, Nykanen RF Septostomy Catheter, Baylis Medical…Summary page 4…e 1: Predicate Devices Predicate Device Manufacturer 510(k) No. Nykanen Radiofrequency Wire Baylis Medical Company Inc. K990284 NRG Transseptal Needle Baylis Medical Company Inc. K073326 Indications for Use The ProTrack RF Anchor Wire… | 2001 |
| * | K073326 | NRG Transseptal NeedleSummary page 4…510(k) No. Nykanen Radiofrequency Wire Baylis Medical Company Inc. K990284 NRG Transseptal Needle Baylis Medical Company Inc. K073326 Indications for Use The ProTrack RF Anchor Wire is indicated for the creation of an atrial septal defect in the heart. Tradi… | 2008 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2025 | Class II | Z-2103-2025 | Packaging change control | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K242076 (Baylis Medical Company, 2024) has gone furthest, with 2 descendants of its own.
How does its category compare?
All DXF devicesDXF Catheter, Septostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 ProTrack RF Anchor Wire is indicated for the creation of an atrial septal defect in the heart.
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/K150709 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150709: ProTrack RF Anchor Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150709
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