510(k) · Cleared
ClearedRadifocus Glidecath (or Radifocus Glidecath XP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · DQO Catheter, Intravascular, Diagnostic
Cleared on Feb 6, 2009 as substantially equivalent to K915414 (Terumo Medical Corp., 1992) after a 31-day review. Its family tree reaches back 1 generation to 1992. 11 later devices descend from it.
- Decided
- Feb 6, 2009
- Review
- 31 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915414 (1992). 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK915414 Terumo Angiogtaphic CatheterTerumo Medical Corp. · 1992
- This deviceK090040 Radifocus Glidecath (or Radifocus Glidecath XP)Terumo Medical Corp. · 2009
- Descendant · cites it directly · 9 of its ownK110459 Surefire Infusion Catheter SystemSurefire Medical, Inc. · 2011
- Descendant · 2 generations on · 7 of its ownK121677 Surefire HI-Flow MicrocatheterSurefire Medical, Inc. · 2012
- Descendant · 3 generations on · 6 of its ownK143588 Surefire Infusion System 021Surefire Medical, Inc. · 2015
- Descendant · 4 generations on · 5 of its ownK160662 Surefire Infusion SystemSurefire Medical, Inc. · 2016
- Descendant · 4 generations on · 4 of its ownK171355 Surefire Precision Infusion SystemSurefire Medical, Inc. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K110459Surefire Infusion Catheter SystemSurefire Medical, Inc. · 2011 · cites it directly9descendants
- K121677Surefire HI-Flow MicrocatheterSurefire Medical, Inc. · 2012 · 2 generations on7descendants
- K143588Surefire Infusion System 021Surefire Medical, Inc. · 2015 · 3 generations on6descendants
- K160662Surefire Infusion SystemSurefire Medical, Inc. · 2016 · 4 generations on5descendants
- K171355Surefire Precision Infusion SystemSurefire Medical, Inc. · 2017 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915414 | Terumo Angiogtaphic Catheter | Terumo Medical Corp. | 1992 | — |
| 0 (this device) | K090040 | Radifocus Glidecath (or Radifocus Glidecath XP) | Terumo Medical Corp. | 2009 | — |
| +1 | K110459 | Surefire Infusion Catheter System | Surefire Medical, Inc. | 2011 | — |
| +2 | K121677 | Surefire HI-Flow Microcatheter | Surefire Medical, Inc. | 2012 | — |
| +3 | K143588 | Surefire Infusion System 021 | Surefire Medical, Inc. | 2015 | — |
| +4 | K160662 | Surefire Infusion System | Surefire Medical, Inc. | 2016 | — |
| +4 | K171355 | Surefire Precision Infusion System | Surefire Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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.
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 |
|---|---|---|---|
| * | K915414 | Terumo Angiogtaphic CatheterSummary page 1…manual process. E. Design / Materials The RADEFOCUS® Glidecath® (or RADIIFOCUS Glidecath XP) in this submission is the same device that was cleared under K91 5414, the Terumo Angiographic Catheter. There are no changes in the design or materials.… | 1992 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090040: Radifocus Glidecath (or Radifocus Glidecath XP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090040
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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