510(k) · Cleared
ClearedBOBBY Balloon Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc., d/b/a Terumo Neuro · QJP Catheter, Percutaneous, Neurovasculature
Cleared on Jun 9, 2026 as substantially equivalent to K193607 (MicroVention, Inc., 2020) after a 29-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Jun 9, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K010954 (2001). No later device cites it as a predicate yet.
- Root · 8 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 7 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 6 generations backK102657 Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2010
- 5 generations backK112404 Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2012 · Recalled
- 4 generations backK122581 Modified Balloon Guide Catheter Model 90253, 90254Concentric Medical, Inc. · 2012 · Recalled
- 3 generations backK131492 Modified Flowgate Balloon Guide CatheterConcentric Medical, Inc. · 2013
- 2 generations backK153729 8F FlowGate2 Balloon Guide CatheterConcentric Medical · 2016 · Recalled
- 1 generation backK193607 BOBBY Balloon Guide CatheterMicroVention, Inc. · 2020 · Recalled
- This deviceK261549 BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo Neuro · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −7 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −6 | K102657 | Concentric Balloon Guide Catheter | Concentric Medical, Inc. | 2010 | — |
| −5 | K112404 | Concentric Balloon Guide Catheter | Concentric Medical, Inc. | 2012 | 1 |
| −4 | K122581 | Modified Balloon Guide Catheter Model 90253, 90254 | Concentric Medical, Inc. | 2012 | 1 |
| −3 | K131492 | Modified Flowgate Balloon Guide Catheter | Concentric Medical, Inc. | 2013 | — |
| −2 | K153729 | 8F FlowGate2 Balloon Guide Catheter | Concentric Medical | 2016 | 2 |
| −1 | K193607 | BOBBY Balloon Guide Catheter | MicroVention, Inc. | 2020 | 1 |
| 0 (this device) | K261549 | BOBBY Balloon Guide Catheter | MicroVention, Inc., d/b/a Terumo Neuro | 2026 | — |
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 QJP? 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 QJP device
- #1 K212838 Benchmark Intracranial Access Systemscore 16.9 · 6 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 |
|---|---|---|---|
| * | K193607 | BOBBY Balloon Guide CatheterSummary page 5…Percutaneous Catheter Product Codes: QJP, DQY CFR Classification: 21 CFR 870.1250 Predicate Device: BOBBY™ Balloon Guide Catheter (K193607) Indications for Use: The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intra… | 2020 |
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 25 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 8 ancestors have a recall of any class.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QJP
22so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QJP
116in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJP
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QJP
688in 2025
MAUDE reports naming product code QJP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 9 | 72 | 0 | 16 |
| 2021 | 12 | 139 | 0 | 29 |
| 2022 | 14 | 206 | 0 | 30 |
| 2023 | 14 | 184 | 0 | 75 |
| 2024 | 18 | 188 | 1 | 130 |
| 2025 | 14 | 116 | 0 | 688 |
| 2026 | 22 | 141 | 0 | — |
What is it indicated for?
The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261549: BOBBY Balloon Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261549
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026