510(k) · Cleared
ClearedRF Tunneler Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Co., Inc. · PDU Catheter For Crossing Total Occlusions
Cleared on Mar 30, 2006 as substantially equivalent to K010265 (Baylis Medical Co., Inc., 2001) and 2 other predicates after a 281-day review. Its family tree reaches back 7 generations to 1989. 6 later devices descend from it.
- Decided
- Mar 30, 2006
- Review
- 281 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K890505 (1989). 27 ancestors in all, the oldest K871011 (1987). 6 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK890505 Usci Grey/Black Guide WireC.R. Bard, Inc. · 1989
- 6 generations backK961271 Usci Commander Series Guide WiresC.R. Bard, Inc. · 1996
- 5 generations backK990639 Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with…Guidant Corp. · 1999
- 4 generations backK011986 Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 3 generations backK021323 Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc. · 2002
- 2 generations backK031842 Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc. · 2003
- 1 generation backK040067 Clirpath Excimer Laser CatheterSpectranetics Corp. · 2004
- This deviceK051670 RF Tunneler WireBaylis Medical Co., Inc. · 2006
- Descendant · cites it directly · 2 of its ownK101615 Powerwire Radiofrequency GuidewireBaylis Medical Co., Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK232562 PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK101599 RVT Cto DeviceRevascular Therapeutics, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK251158 PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK140288 Truepath Cto DeviceBoston Scientific Corp · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K101615Powerwire Radiofrequency GuidewireBaylis Medical Co., Inc. · 2010 · cites it directly2descendants
- K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc. · 2024 · 2 generations on1descendant
- K101599RVT Cto DeviceRevascular Therapeutics, Inc. · 2011 · cites it directly1descendant
- K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc. · 2025 · 3 generations on0descendants
- K140288Truepath Cto DeviceBoston Scientific Corp · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K890505 | Usci Grey/Black Guide Wire | C.R. Bard, Inc. | 1989 | — |
| −6 | K961271 | Usci Commander Series Guide Wires | C.R. Bard, Inc. | 1996 | — |
| −5 | K990639 | Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat… | Guidant Corp. | 1999 | — |
| −4 | K011986 | Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −3 | K021323 | Modification to Safe-Steer Guide Wire System | Intra Luminal Therapeutics, Inc. | 2002 | — |
| −2 | K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing System | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −1 | K040067 | Clirpath Excimer Laser Catheter | Spectranetics Corp. | 2004 | — |
| 0 (this device) | K051670 | RF Tunneler Wire | Baylis Medical Co., Inc. | 2006 | — |
| +1 | K101615 | Powerwire Radiofrequency Guidewire | Baylis Medical Co., Inc. | 2010 | — |
| +2 | K232562 | PowerWire Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | 2024 | — |
| +1 | K101599 | RVT Cto Device | Revascular Therapeutics, Inc. | 2011 | — |
| +3 | K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | 2025 | — |
| +2 | K140288 | Truepath Cto Device | Boston Scientific Corp | 2014 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 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? (3)
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 |
|---|---|---|---|
| * | K010265 | Baylis Medical RF Perforation Probe, Model RFP-265Summary page 1…edicate Devices Predicate devices are the Baylis Medical RF Perforation Probe (Baylis Medical Company Inc.), which is cleared under 510(k) Premarket Notification number K010265; the Safe-Cross Radio Frequency Total Occlusion Crossing System (IntraLuminal Therapeutics Inc.), which is cleared under 510(k) P… | 2001 |
| * | K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing SystemSummary page 1…ber K010265; the Safe-Cross Radio Frequency Total Occlusion Crossing System (IntraLuminal Therapeutics Inc.), which is cleared under 510(k) Premarket Notification number K031842; and the CLiRpath Excimer Laser Catheter (Spectranetics Corp.), which is cleared under 510(k) Premarket Notification number K040… | 2003 |
| * | K040067 | Clirpath Excimer Laser CatheterSummary page 1…510(k) Premarket Notification number K031842; and the CLiRpath Excimer Laser Catheter (Spectranetics Corp.), which is cleared under 510(k) Premarket Notification number K040067. Device Description The RE Tunneler Wire consists of a core wire surrounded with a polymer insulation. The wire… | 2004 |
What descends from it? (6)
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)
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 17 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K101615 (Baylis Medical Co., Inc., 2010) has gone furthest, with 2 descendants of its own.
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.
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 RF Tunneler Wire is intended to create a
channel in tofally occluded peripheral vessels
3 mm or greater.
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/K051670 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051670: RF Tunneler Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051670
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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