510(k) · Cleared
ClearedBranchor Balloon Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asahi Intecc Co., Ltd. · QJP Catheter, Percutaneous, Neurovasculature
Cleared on Oct 11, 2022 as substantially equivalent to K203723 (Asahi Intecc Co., Ltd., 2021) after a 98-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Oct 11, 2022
- Review
- 98 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010954 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 3 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 2 generations backK120781 Cello Balloon Guide Catheter (6F), 950 MM and 1020 MM LengthFuji Systems Corp. · 2012
- 1 generation backK203723 Branchor Balloon Guide CatheterAsahi Intecc Co., Ltd. · 2021
- This deviceK221951 Branchor Balloon Guide CatheterAsahi Intecc Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK251240 Branchor X Balloon Guide CatheterAsahi Intecc Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251240Branchor X Balloon Guide CatheterAsahi Intecc Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −3 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −2 | K120781 | Cello Balloon Guide Catheter (6F), 950 MM and 1020 MM Length | Fuji Systems Corp. | 2012 | — |
| −1 | K203723 | Branchor Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2021 | — |
| 0 (this device) | K221951 | Branchor Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2022 | — |
| +1 | K251240 | Branchor X Balloon Guide Catheter | Asahi Intecc Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 |
|---|---|---|---|
| * | K203723 | Branchor Balloon Guide CatheterSummary page 4…Catheter PRODUCT CODE: QJP, Catheter, Percutaneous, Neurovasculature PREDICATE DEVICE: Branchor Balloon Guide Catheter (K203723) Device Description: The Branchor Balloon Guide Catheter has the same design, materials and accessories as the predicate dev… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251240 | Branchor X Balloon Guide Catheter | 2025 | 0 |
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 21 years and passes through 3 companies; a new generation was cleared every 9.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K251240 (Asahi Intecc Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Branchor Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.
The balloon provides temporary vascular occlusion during these procedures.
The Branchor Balloon Guide Catheter can also be used as a conduit for retrieval devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221951: Branchor 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/K221951
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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