510(k) · Cleared
ClearedBaylis Medical RF Septostomy Generator, Nykanen RF Septostomy Catheter, Baylis Medical Connector Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Co., Inc. · DXF Catheter, Septostomy
Cleared on Feb 1, 2001 after a 734-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Feb 1, 2001
- Review
- 734 days
- Class
- Class II
- Product code
- DXF
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK990284 Baylis Medical RF Septostomy Generator, Nykanen RF Septostomy…Baylis Medical Co., Inc. · 2001
- Descendant · cites it directly · 7 of its ownK150709 ProTrack RF Anchor WireBaylis Medical Company, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 2 of its ownK242076 VersaCross™ RF WireBaylis Medical Company · 2024
- Descendant · 2 generations on · 2 of its ownK240900 HOTWIRE™ RF GuidewireAtraverse Medical · 2024
- Descendant · 3 generations on · 1 of its ownK252419 Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK261745 LightningWire Transseptal Puncture System (TPS)ElectroWire Medical · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K150709ProTrack RF Anchor WireBaylis Medical Company, Inc. · 2015 · cites it directly7descendants
- K242076VersaCross™ RF WireBaylis Medical Company · 2024 · 2 generations on2descendants
- K240900HOTWIRE™ RF GuidewireAtraverse Medical · 2024 · 2 generations on2descendants
- K252419Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical, Inc. · 2025 · 3 generations on1descendant
- K261745LightningWire Transseptal Puncture System (TPS)ElectroWire Medical · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990284 | Baylis Medical RF Septostomy Generator, Nykanen RF Septostomy Catheter, Baylis… | Baylis Medical Co., Inc. | 2001 | — |
| +1 | K150709 | ProTrack RF Anchor Wire | Baylis Medical Company, Inc. | 2015 | 1 |
| +2 | K242076 | VersaCross™ RF Wire | Baylis Medical Company | 2024 | — |
| +2 | K240900 | HOTWIRE™ RF Guidewire | Atraverse Medical | 2024 | — |
| +3 | K252419 | Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX) | Atraverse Medical, Inc. | 2025 | — |
| +2 | K261745 | LightningWire Transseptal Puncture System (TPS) | ElectroWire Medical | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150709 | ProTrack RF Anchor Wire | 2015 | 7 |
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?
- Of its descendants, K150709 (Baylis Medical Company, Inc., 2015) has gone furthest, with 7 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.
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?
To create an atrial septal defect in the heart.
Transseptal left heart access.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990284 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990284: Baylis Medical RF Septostomy Generator, Nykanen RF Septostomy Catheter, Baylis Medical Connector Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990284
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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