510(k) · Cleared
ClearedCatheter, Balloon Type
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interventional Therapeutics Corp. · DQO Catheter, Intravascular, Diagnostic
Cleared on Oct 5, 1995 after a 246-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Oct 5, 1995
- Review
- 246 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK950398 Catheter, Balloon TypeInterventional Therapeutics Corp. · 1995
- Descendant · cites it directly · 6 of its ownK993292 Boston Scientific/Target Sentry Occlusion Balloon CatheterBoston Scientific, Target · 2000
- Descendant · 2 generations on · 4 of its ownK080861 Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation · 2008
- Descendant · 3 generations on · 3 of its ownK091504 Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit…Micrus Endovascular Corporation · 2009
- Descendant · 4 generations on · 2 of its ownK103780 Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent…Micrus Endovascular Corporation · 2011
- Descendant · 5 generations on · 1 of its ownK142692 Occlusion Balloon CatheterEmbolx, Inc. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K993292Boston Scientific/Target Sentry Occlusion Balloon CatheterBoston Scientific, Target · 2000 · cites it directly6descendants
- K080861Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation · 2008 · 2 generations on4descendants
- K091504Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon…Micrus Endovascular Corporation · 2009 · 3 generations on3descendants
- K103780Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon…Micrus Endovascular Corporation · 2011 · 4 generations on2descendants
- K142692Occlusion Balloon CatheterEmbolx, Inc. · 2015 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950398 | Catheter, Balloon Type | Interventional Therapeutics Corp. | 1995 | — |
| +1 | K993292 | Boston Scientific/Target Sentry Occlusion Balloon Catheter | Boston Scientific, Target | 2000 | — |
| +2 | K080861 | Micrus Ascent Occlusion Balloon Catheter | Micrus Endovascular Corporation | 2008 | — |
| +3 | K091504 | Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion… | Micrus Endovascular Corporation | 2009 | — |
| +4 | K103780 | Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion… | Micrus Endovascular Corporation | 2011 | — |
| +5 | K142692 | Occlusion Balloon Catheter | Embolx, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993292 | Boston Scientific/Target Sentry Occlusion Balloon Catheter | 2000 | 6 |
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?
- Of its descendants, K993292 (Boston Scientific, Target, 2000) has gone furthest, with 6 descendants of its own.
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) | — |
https://510kreport.com/device/K950398 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950398: Catheter, Balloon Type.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950398
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026