510(k) · Decided
DecidedPowerWire® 14 Radiofrequency Guidewire Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Technologies, Inc. · PDU Catheter For Crossing Total Occlusions
Cleared on Sep 11, 2025 as substantially equivalent to K232562 (Baylis Medical Technologies, Inc., 2024) after a 149-day review. Its family tree reaches back 10 generations to 1989.
- Decided
- Sep 11, 2025
- Review
- 149 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K890505 (1989). 30 ancestors in all, the oldest K871011 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 6 generations between
- 3 generations backK051670 RF Tunneler WireBaylis Medical Co., Inc. · 2006
- 2 generations backK101615 Powerwire Radiofrequency GuidewireBaylis Medical Co., Inc. · 2010
- 1 generation backK232562 PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc. · 2024
- This deviceK251158 PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 9 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 8 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 7 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 6 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 5 generations backK031842 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003
- 4 generations backK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- 3 generations backK051670 RF Tunneler WireBaylis Medical Co., Inc. · 2006
- 2 generations backK101615 Powerwire Radiofrequency GuidewireBaylis Medical Co., Inc. · 2010
- 1 generation backK232562 PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc. · 2024
- This deviceK251158 PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −9 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −8 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −7 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −6 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −5 | K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −4 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| −3 | K051670 | RF Tunneler Wire | Baylis Medical Co., Inc. | 2006 | — |
| −2 | K101615 | Powerwire Radiofrequency Guidewire | Baylis Medical Co., Inc. | 2010 | — |
| −1 | K232562 | PowerWire Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | 2024 | — |
| 0 (this device) | K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 5 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 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 PDU? 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 PDU device
- #1 K262013 Kiba CTO Crossing Catheterscore 15.2 · 12 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 |
|---|---|---|---|
| * | K232562 | PowerWire Radiofrequency Guidewire KitSummary page 5…PDU III. Identification of Predicate Device The predicate device is the PowerWire Radiofrequency Guidewire, which is cleared under 510(k) Premarket Notification Number K232562 (cleared 28-Feb-2024). This predicate device has not been the subject of a design-related recall. IV. Device Description PowerW… | 2024 |
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 36 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 30 ancestors has a recall of any class.
How does its category compare?
All PDU devicesPDU Catheter For Crossing Total Occlusions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PDU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PDU
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDU
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PDU
179in 2025
MAUDE reports naming product code PDU, 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 | 4 | 66 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 3 | 49 | 0 | 0 |
| 2011 | 3 | 91 | 0 | 0 |
| 2012 | 6 | 68 | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 3 | 97 | 0 | 10 |
| 2015 | 2 | — | 0 | 12 |
| 2016 | 2 | — | 0 | 26 |
| 2017 | 1 | — | 0 | 211 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 1 | — | 0 | 83 |
| 2020 | 2 | — | 2 | 129 |
| 2021 | 3 | 144 | 0 | 189 |
| 2022 | 4 | 139 | 0 | 156 |
| 2023 | 3 | 221 | 1 | 71 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 3 | 59 | 0 | 179 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The PowerWire® 14 Radiofrequency Guidewire is intended to create a channel in totally occluded peripheral vessels 3 mm or greater, including vessels with stents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251158: PowerWire® 14 Radiofrequency Guidewire Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251158
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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