510(k) · Cleared
ClearedAsahi Angiographic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Intecc Co., Ltd. · DQO Catheter, Intravascular, Diagnostic
Cleared on Nov 2, 2005 as substantially equivalent to K960975 (Cordis Corp., 1996) and 2 other predicates after a 142-day review. Its family tree reaches back 3 generations to 1992. 1 of the 8 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Nov 2, 2005
- Review
- 142 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K921310 (1992). 5 ancestors in all, the oldest K862006 (1986). 2 later devices descend from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK921310 Cordis 6 French Paragon Angiographic CatheterCordis Corp. · 1992
- 2 generations backK960975 1-4F Infiniti Angiographic CatheterCordis Corp. · 1996 · Recalled
- 1 generation backK970854 5 FR and 6 FR Infiniti Angiographic CatheterCordis Corp. · 1997 · Recalled (Class I)
- This deviceK051561 Asahi Angiographic CatheterAsahi Intecc Co., Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK082559 Spectranetics Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp. · 2008
- Descendant · 2 generations on · 0 of its ownK090913 Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp. · 2009
Class I recalls in this family
- K970854 5 FR and 6 FR Infiniti Angiographic Catheterdirect predicate · 1997
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921310 | Cordis 6 French Paragon Angiographic Catheter | Cordis Corp. | 1992 | — |
| −2 | K960975 | 1-4F Infiniti Angiographic Catheter | Cordis Corp. | 1996 | 1 |
| −1 | K970854 | 5 FR and 6 FR Infiniti Angiographic Catheter | Cordis Corp. | 1997 | Class I |
| 0 (this device) | K051561 | Asahi Angiographic Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| +1 | K082559 | Spectranetics Cross-Pilot Turbo Elite Support Catheter | Spectranetics Corp. | 2008 | — |
| +2 | K090913 | Cross-Pilot Turbo Elite Support Catheter | Spectranetics Corp. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 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.
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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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 |
|---|---|---|---|
| * | K960975 | 1-4F Infiniti Angiographic CatheterSummary page 1…ahi Angiographic Catheter Classification Name: Diagnostic intravascular catheter (per 21 CFR 870.1200) Classification: Class II Predicate Device: K960975: 4F Infiniti Angiographic Catheter K970854: 5F and 6F Infiniti Angiographic Catheter… | 1996 |
| * | K970854 | 5 FR and 6 FR Infiniti Angiographic CatheterSummary page 1…ascular catheter (per 21 CFR 870.1200) Classification: Class II Predicate Device: K960975: 4F Infiniti Angiographic Catheter K970854: 5F and 6F Infiniti Angiographic Catheter K862006: Stand & High Flow Femoral- Ventricular Pigtail Cathe… | 1997 |
| * | K862006 | Stand & High Flow Femoral-Ventricular Pigtail CathSummary page 1…redicate Device: K960975: 4F Infiniti Angiographic Catheter K970854: 5F and 6F Infiniti Angiographic Catheter K862006: Stand & High Flow Femoral- Ventricular Pigtail Catheter Device Description: The Asahi Angiographic Catheter consists, as its… | 1986 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082559 | Spectranetics Cross-Pilot Turbo Elite Support Catheter | 2008 | 1 |
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.
- K9708545 FR and 6 FR Infiniti Angiographic CatheterCordis Corp. · 1997 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K082559 (Spectranetics Corp., 2008) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K960975.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The Asahi Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051561 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051561: Asahi Angiographic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051561
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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