510(k) · Cleared
ClearedModified Flowgate Balloon Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Concentric Medical, Inc. · DQY Catheter, Percutaneous
Cleared on Oct 3, 2013 as substantially equivalent to K112404 (Concentric Medical, Inc., 2012) and 1 other predicate after a 133-day review. Its family tree reaches back 5 generations to 2001. 13 later devices descend from it.
- Decided
- Oct 3, 2013
- Review
- 133 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010954 (2001). 13 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 4 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 3 generations backK102657 Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2010
- 2 generations backK112404 Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2012 · Recalled
- 1 generation backK122581 Modified Balloon Guide Catheter Model 90253, 90254Concentric Medical, Inc. · 2012 · Recalled
- This deviceK131492 Modified Flowgate Balloon Guide CatheterConcentric Medical, Inc. · 2013
- Descendant · cites it directly · 10 of its ownK153729 8F FlowGate2 Balloon Guide CatheterConcentric Medical · 2016 · Recalled
- Descendant · cites it directly · 1 of its ownK242392 Path BGCCrossroads Neurovascular, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK212340 EMBOGUARD Balloon Guide CatheterNeuravi Limited · 2021
- Descendant · 2 generations on · 1 of its ownK193607 BOBBY Balloon Guide CatheterMicroVention, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK200910 BOSS Balloon Guide CatheterMarblehead Medical · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K1537298F FlowGate2 Balloon Guide CatheterConcentric Medical · 2016 · cites it directly10descendants
- K242392Path BGCCrossroads Neurovascular, Inc. · 2025 · cites it directly1descendant
- K212340EMBOGUARD Balloon Guide CatheterNeuravi Limited · 2021 · 2 generations on1descendant
- K193607BOBBY Balloon Guide CatheterMicroVention, Inc. · 2020 · 2 generations on1descendant
- K200910BOSS Balloon Guide CatheterMarblehead Medical · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −4 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −3 | K102657 | Concentric Balloon Guide Catheter | Concentric Medical, Inc. | 2010 | — |
| −2 | K112404 | Concentric Balloon Guide Catheter | Concentric Medical, Inc. | 2012 | 1 |
| −1 | K122581 | Modified Balloon Guide Catheter Model 90253, 90254 | Concentric Medical, Inc. | 2012 | 1 |
| 0 (this device) | K131492 | Modified Flowgate Balloon Guide Catheter | Concentric Medical, Inc. | 2013 | — |
| +1 | K153729 | 8F FlowGate2 Balloon Guide Catheter | Concentric Medical | 2016 | 2 |
| +1 | K242392 | Path BGC | Crossroads Neurovascular, Inc. | 2025 | — |
| +2 | K212340 | EMBOGUARD Balloon Guide Catheter | Neuravi Limited | 2021 | — |
| +2 | K193607 | BOBBY Balloon Guide Catheter | MicroVention, Inc. | 2020 | 1 |
| +2 | K200910 | BOSS Balloon Guide Catheter | Marblehead Medical | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 DQY? 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 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? (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 |
|---|---|---|---|
| * | K112404 | Concentric Balloon Guide CatheterSummary page 1…Principal Regulatory Affairs Specialist Date Prepared: September 27, 2013 Predicate Device: Concentric Balloon Guide Catheter (K1 12404) Modified Concentric Balloon Guide Catheter (K122581) Device Description Like the predicate device,… | 2012 |
| * | K122581 | Modified Balloon Guide Catheter Model 90253, 90254Summary page 1…September 27, 2013 Predicate Device: Concentric Balloon Guide Catheter (K1 12404) Modified Concentric Balloon Guide Catheter (K122581) Device Description Like the predicate device, the Modified FlowGatew Balloon Guide Catheter is a coaxial- lumen, braid-reinforce… | 2012 |
What descends from it? (13)
See all 132 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?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 10 months on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K153729 (Concentric Medical, 2016) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K112404.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
What is it indicated for?
The Concentric Balloon Guide Catheter is indicated 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/K131492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131492: Modified Flowgate 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/K131492
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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