510(k) · Cleared
ClearedRoyal Flush Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DQO Catheter, Intravascular, Diagnostic
Cleared on Jan 25, 2018 as substantially equivalent to K122937 (Cook, Inc., 2012) and 1 other predicate after a 269-day review. Its family tree reaches back 4 generations to 1996. 1 of the 8 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 25, 2018
- Review
- 269 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K960806 (1996). 7 ancestors in all, the oldest K882796 (1988). No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK960806 Turbo TrackerTarget Therapeutics · 1996
- 3 generations backK032624 Micrus MicrocatheterMicrus Corp. · 2003
- 2 generations backK060116 Micrus Courier MicrocathetersMicrus Endovascular Corporation · 2006
- 1 generation backK113819 Mongoose Angiographic CatheterPediacath, Inc. · 2012
- This deviceK171264 Royal Flush CatheterCook Incorporated · 2018
Class I recalls in this family
- K122937 Slip-Cath Beacon Tip Catheter Model SCBR…direct predicate · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960806 | Turbo Tracker | Target Therapeutics | 1996 | — |
| −3 | K032624 | Micrus Microcatheter | Micrus Corp. | 2003 | — |
| −2 | K060116 | Micrus Courier Microcatheters | Micrus Endovascular Corporation | 2006 | — |
| −1 | K113819 | Mongoose Angiographic Catheter | Pediacath, Inc. | 2012 | — |
| 0 (this device) | K171264 | Royal Flush Catheter | Cook Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 2012 | 1 | 1 |
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? (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 |
|---|---|---|---|
| * | K122937 | Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath…Summary page 4…The Royal Flush® Catheter, subject of this submission, is substantially equivalent to the primary predicate Slip-Cath® Beacon® Tip Catheter cleared under 510(k) number K122937 and the secondary predicate Mongoose® Pediatric Angiography Catheters cleared under 510(k) number K113819. Cook I… | 2012 |
| * | K113819 | Mongoose Angiographic CatheterSummary page 4…ate Slip-Cath® Beacon® Tip Catheter cleared under 510(k) number K122937 and the secondary predicate Mongoose® Pediatric Angiography Catheters cleared under 510(k) number K113819. Cook Incorporated 2 Royal Flush Cathet… | 2012 |
| † | K162448 | White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K122937Slip-Cath Beacon Tip Catheter Model SCBR (Product Prefix), Shuttle Select Slip-Cath Catheter Model SCBR…Cook, Inc. · 2012 · Direct predicate · ◆ in the 2012 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 6.2 years on median.
- 2 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- 7 other devices also cite its predicate K122937.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Royal Flush Catheter are intended for the delivery of contrast media to the peripheral and coronary vasculature, not including the neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171264: Royal Flush Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171264
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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