510(k) · Cleared
ClearedAsahi Tornus Support Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Intecc Co., Ltd. · DQY Catheter, Percutaneous
Cleared on Sep 26, 2005 as substantially equivalent to K032660 (Xtrak Medical, Inc., 2003) and 1 other predicate after an 88-day review. Its family tree reaches back 4 generations to 2000. 1 of the 124 devices in its family, counting itself, has a Class I recall. 119 later devices descend from it.
- Decided
- Sep 26, 2005
- Review
- 88 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K001992 (2000). 119 later devices descend from it, 10 citing it directly. 1 of the 124 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK001992 Ilt 0.014 Catheter, Model C114NL2Intra Luminal Therapeutics, Inc. · 2000
- 3 generations backK012169 Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter…Intra Luminal Therapeutics, Inc. · 2001
- 2 generations backK030984 Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter…Intra Luminal Therapeutics, Inc. · 2003
- 1 generation backK032660 Xtrak Support CatheterXtrak Medical, Inc. · 2003
- This deviceK051772 Asahi Tornus Support CatheterAsahi Intecc Co., Ltd. · 2005
- Descendant · cites it directly · 44 of its ownK070372 Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support…Vascular Solutions, Inc. · 2007
- Descendant · cites it directly · 34 of its ownK062885 Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007
- Descendant · cites it directly · 33 of its ownK083127 Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009
- Descendant · cites it directly · 22 of its ownK060745 Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006
- Descendant · 2 generations on · 21 of its ownK083313 Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K141547 Wingman Extendable Tip Support Catheter6 generations on · 2014
Most influential descendants
Showing 5 of 119 · See all- K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Vascular Solutions, Inc. · 2007 · cites it directly44descendants
- K062885Stride MicrocatheterAsahi Intecc Co., Ltd. · 2007 · cites it directly34descendants
- K083127Asahi Corsair MicrocatheterAsahi Intecc Co., Ltd. · 2009 · cites it directly33descendants
- K060745Asahi Tornus Support Catheter with Torque Device AccessoryAsahi Intecc Co., Ltd. · 2006 · cites it directly22descendants
- K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc. · 2009 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001992 | Ilt 0.014 Catheter, Model C114NL2 | Intra Luminal Therapeutics, Inc. | 2000 | — |
| −3 | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing… | Intra Luminal Therapeutics, Inc. | 2001 | — |
| −2 | K030984 | Safe Cross Angled Support 0.14, Safe Cross Straight Support Catheter 0.14… | Intra Luminal Therapeutics, Inc. | 2003 | — |
| −1 | K032660 | Xtrak Support Catheter | Xtrak Medical, Inc. | 2003 | — |
| 0 (this device) | K051772 | Asahi Tornus Support Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| +1 | K070372 | Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model… | Vascular Solutions, Inc. | 2007 | — |
| +1 | K062885 | Stride Microcatheter | Asahi Intecc Co., Ltd. | 2007 | — |
| +1 | K083127 | Asahi Corsair Microcatheter | Asahi Intecc Co., Ltd. | 2009 | — |
| +1 | K060745 | Asahi Tornus Support Catheter with Torque Device Accessory | Asahi Intecc Co., Ltd. | 2006 | — |
| +2 | K083313 | Wildcat 7F Guidewire Support Catheter | Avinger, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 7 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 17 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 1 |
| 2015 | 9 | 0 |
| 2016 | 12 | 0 |
| 2017 | 8 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 8 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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.
1 device in this family has 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 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 |
|---|---|---|---|
| * | K032660 | Xtrak Support CatheterSummary page 1…Percutaneous Catheter DEVICE Class 2 per 21 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: XTRAK Support Catheter (K032660) ILT Support Catheter (K(012169) DESCRIPTION OFTHE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The ASAHI… | 2003 |
| * | K012169 | Ilt Support Catheter .014, Model C114LW1; Ilt Support Catheter Advancing Mechanism…Summary page 1…2 per 21 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: XTRAK Support Catheter (K032660) ILT Support Catheter (K(012169) DESCRIPTION OFTHE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The ASAHI Tornus support catheter is a device that is intended to… | 2001 |
What descends from it? (119)
See all 11910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070372 | Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610 | 2007 | 44 |
| K062885 | Stride Microcatheter | 2007 | 34 |
| K083127 | Asahi Corsair Microcatheter | 2009 | 33 |
| K060745 | Asahi Tornus Support Catheter with Torque Device Accessory | 2006 | 22 |
| K081130 | Bridgepoint Medical Crossboss Percutaneous Coronary Catheter | 2009 | 14 |
| K082339 | Enabler-P Support Catheter | 2008 | 14 |
| K083833 | Enabler-P Catheter, 1000 Part Number:1160 | 2009 | 12 |
| K082519 | Finecross MG Coronary Micro-Guide Catheter | 2008 | 9 |
| K142065 | Turnpike Catheter | 2014 | 4 |
| K112886 | Upstream Support Catheter | 2012 | 0 |
Has anything in its family been recalled? (1 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.
- K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K070372 (Vascular Solutions, Inc., 2007) has gone furthest, with 44 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The ASAHI Tornus support catheter is intended to be used in conjunction with a
steerable guidewire to access discrete regions of the vasculature and for guidewire
exchange.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051772 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051772: Asahi Tornus Support Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051772
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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