510(k) · Cleared
ClearedHeartrail Iii Guiding Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Corporation · DQO Catheter, Intravascular, Diagnostic
Cleared on Jul 16, 2012 as substantially equivalent to K092372 (Terumo Corp., 2009) after a 245-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Jul 16, 2012
- Review
- 245 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921310 (1992). 10 ancestors in all, the oldest K863137 (1986). No later device cites it as a predicate yet.
- Root · 5 generations backK921310 Cordis 6 French Paragon Angiographic CatheterCordis Corp. · 1992
- 4 generations backK960975 1-4F Infiniti Angiographic CatheterCordis Corp. · 1996 · Recalled
- 3 generations backK992051 Radifocus OptitorqueTerumo Medical Corp. · 1999
- 2 generations backK082736 Radifocus Optitorque Angiographic CatheterTerumo Medical Corp. · 2008
- 1 generation backK092372 Heartrail Iii Guiding CatheterTerumo Corp. · 2009
- This deviceK113335 Heartrail Iii Guiding CatheterTerumo Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921310 | Cordis 6 French Paragon Angiographic Catheter | Cordis Corp. | 1992 | — |
| −4 | K960975 | 1-4F Infiniti Angiographic Catheter | Cordis Corp. | 1996 | 1 |
| −3 | K992051 | Radifocus Optitorque | Terumo Medical Corp. | 1999 | — |
| −2 | K082736 | Radifocus Optitorque Angiographic Catheter | Terumo Medical Corp. | 2008 | — |
| −1 | K092372 | Heartrail Iii Guiding Catheter | Terumo Corp. | 2009 | — |
| 0 (this device) | K113335 | Heartrail Iii Guiding Catheter | Terumo Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 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 DQO? 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? (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 |
|---|---|---|---|
| * | K092372 | Heartrail Iii Guiding CatheterSummary page 2…ion Name: Catheter, Intravascular, Diagnostic 3) Predicate Device The predicate device is the Teruino Heartrail"' III Guiding Catheter cleared under K092372. The differences between the devices do not raise any new issues of safety or effectiveness. 4) Description The H… | 2009 |
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 20 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K092372.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 HeartrailTM III Guiding Catheter is intended for cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the radial artery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113335 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113335: Heartrail Iii Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113335
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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