510(k) · Cleared
ClearedKiba CTO Crossing Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reflow Medical, Inc. · PDU Catheter For Crossing Total Occlusions
Cleared on Aug 28, 2026 as substantially equivalent to K193596 (Reflow Medical, 2020) after a 74-day review. Its family tree reaches back 12 generations to 1994. 3 of the 61 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 28, 2026
- Review
- 74 days
- Class
- Class II
- Product code
- PDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K931794 (1994). 60 ancestors in all, the oldest K884647 (1989). No later device cites it as a predicate yet. 3 of the 61 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
- 8 generations between
- 3 generations backK120129 Mantaray CatheterBridgepoint Medical · 2012
- 2 generations backK120533 Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012
- 1 generation backK193596 Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical · 2020
- This deviceK262013 Kiba CTO Crossing CatheterReflow Medical, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
- 11 generations backK974683 Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
- 10 generations backK012749 Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002
- 9 generations backK040922 Venture Wire Control CatheterVelocimed, Inc. · 2004 · Recalled (Class I)
- 8 generations backK042910 Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · Recalled (Class I)
- 7 generations backK061843 Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · Recalled (Class I)
- 6 generations backK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
- 5 generations backK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
- 4 generations backK111963 Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011
- 3 generations backK120129 Mantaray CatheterBridgepoint Medical · 2012
- 2 generations backK120533 Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012
- 1 generation backK193596 Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical · 2020
- This deviceK262013 Kiba CTO Crossing CatheterReflow Medical, Inc. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931794 | Marinr Series EP Diagnostic Catheters | Medtronic Cardiorhythm | 1994 | — |
| −11 | K974683 | Naviport Deflectable Tip Guiding Catheter | Cardima, Inc. | 1999 | — |
| −10 | K012749 | Biocardia Universal Deflectable Guide Catheter, Model 000664 | Biocardia, Inc. | 2002 | — |
| −9 | K040922 | Venture Wire Control Catheter | Velocimed, Inc. | 2004 | Class I |
| −8 | K042910 | Venture Wire Control Catheter, Model WCC | Velocimed, Inc. | 2004 | Class I |
| −7 | K061843 | Venture Wire Control Catheter, Model WCC | St Jude Medical | 2006 | Class I |
| −6 | K080987 | Bridgepoint Medical Stingray Device and Accessories | Bridgepoint Medical | 2009 | 1 |
| −5 | K101591 | Stingray Orienting Balloon Catheter | Bridgepoint Medical | 2010 | 1 |
| −4 | K111963 | Bridgepoint Medical Mantaray (TM) Catheter | Bridgepoint Medical | 2011 | — |
| −3 | K120129 | Mantaray Catheter | Bridgepoint Medical | 2012 | — |
| −2 | K120533 | Bigboss Catheters Mantatay Catheter Mantaray Guidewires | Bridgepoint Medical | 2012 | — |
| −1 | K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35 | Reflow Medical | 2020 | — |
| 0 (this device) | K262013 | Kiba CTO Crossing Catheter | Reflow Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 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.
3 devices in this family have a Class I recall. 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 K251158 PowerWire® 14 Radiofrequency Guidewire Kitscore 12.7 · 10 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 |
|---|---|---|---|
| * | K193596 | Wingman 14, Wingman 14C, Wingman 18, Wingman 35Summary page 5…cation Name: Percutaneous Catheter Regulatory Class: 2 Product Code: PDU, DQY Legally Marketed Predicate: K193596 Device to which your Device Name: Wingman Crossing Catheter firm is claiming No reference devices were used in th… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · 7 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 8 companies; a new generation was cleared every 2.5 years on median.
- 10 of the 60 ancestors have a recall of any class; 3 have a Class I recall.
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. 2026, 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 Kiba CTO Crossing Catheter is intended to be used in conjuction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices, including facilitation of the intraluminal placment of diagnostic/ interventional devices beyond stenotic lesions (including chronic total occlusions [CTOs]) and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents. The Kiba CTO Crossing Catheter is contraindicated for use in the coronary and cerebral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262013: Kiba CTO Crossing Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262013
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026