510(k) · Cleared
Recalled · Class II · 20248F FlowGate2 Balloon Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Concentric Medical · DQY Catheter, Percutaneous
Cleared on Jan 27, 2016 as substantially equivalent to K131492 (Concentric Medical, Inc., 2013) after a 30-day review. Its family tree reaches back 6 generations to 2001. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 27, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010954 (2001). 10 later devices descend from it, 7 citing it directly.
- Root · 6 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 5 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 4 generations backK102657 Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2010
- 3 generations backK112404 Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2012 · Recalled
- 2 generations backK122581 Modified Balloon Guide Catheter Model 90253, 90254Concentric Medical, Inc. · 2012 · Recalled
- 1 generation backK131492 Modified Flowgate Balloon Guide CatheterConcentric Medical, Inc. · 2013
- This deviceK153729 8F FlowGate2 Balloon Guide CatheterConcentric Medical · 2016
- Descendant · cites it directly · 1 of its ownK212340 EMBOGUARD Balloon Guide CatheterNeuravi Limited · 2021
- Descendant · cites it directly · 1 of its ownK193607 BOBBY Balloon Guide CatheterMicroVention, Inc. · 2020 · Recalled
- Descendant · cites it directly · 1 of its ownK200910 BOSS Balloon Guide CatheterMarblehead Medical · 2020
- Descendant · 2 generations on · 0 of its ownK261549 BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo Neuro · 2026
- Descendant · 2 generations on · 0 of its ownK233924 EMBOGUARD Balloon Guide CatheterNeuravi Limited · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K212340EMBOGUARD Balloon Guide CatheterNeuravi Limited · 2021 · cites it directly1descendant
- K193607BOBBY Balloon Guide CatheterMicroVention, Inc. · 2020 · cites it directly1descendant
- K200910BOSS Balloon Guide CatheterMarblehead Medical · 2020 · cites it directly1descendant
- K261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo Neuro · 2026 · 2 generations on0descendants
- K233924EMBOGUARD Balloon Guide CatheterNeuravi Limited · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −5 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −4 | K102657 | Concentric Balloon Guide Catheter | Concentric Medical, Inc. | 2010 | — |
| −3 | K112404 | Concentric Balloon Guide Catheter | Concentric Medical, Inc. | 2012 | 1 |
| −2 | K122581 | Modified Balloon Guide Catheter Model 90253, 90254 | Concentric Medical, Inc. | 2012 | 1 |
| −1 | K131492 | Modified Flowgate Balloon Guide Catheter | Concentric Medical, Inc. | 2013 | — |
| 0 (this device) | K153729 | 8F FlowGate2 Balloon Guide Catheter | Concentric Medical | 2016 | — |
| +1 | K212340 | EMBOGUARD Balloon Guide Catheter | Neuravi Limited | 2021 | — |
| +1 | K193607 | BOBBY Balloon Guide Catheter | MicroVention, Inc. | 2020 | 1 |
| +1 | K200910 | BOSS Balloon Guide Catheter | Marblehead Medical | 2020 | — |
| +2 | K261549 | BOBBY Balloon Guide Catheter | MicroVention, Inc., d/b/a Terumo Neuro | 2026 | — |
| +2 | K233924 | EMBOGUARD Balloon Guide Catheter | Neuravi Limited | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | K131492 | Modified Flowgate Balloon Guide CatheterSummary page 4…gulatory Affairs Specialist Date Prepared: December 22, 2015 Predicate Device: Primary Predicate Device K131492 Modified FlowGate™ Balloon Guide Catheter… | 2013 |
| † | K122581 | Modified Balloon Guide Catheter Model 90253, 90254 | 2012 |
What descends from it? (10)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212340 | EMBOGUARD Balloon Guide Catheter | 2021 | 1 |
| K193607 | BOBBY Balloon Guide Catheter | 2020 | 1 |
| K200910 | BOSS Balloon Guide Catheter | 2020 | 1 |
| K232437 | Paragon 8F Balloon Guide Catheter | 2023 | 0 |
| K221846 | Artix Ballon Guiding Sheath | 2022 | 0 |
| K192525 | 087 Balloon Guide Catheter System | 2019 | 0 |
| K190749 | 087 Balloon Guide Catheter System | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2024 | Class II | Z-1907-2024 | Process design | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin… |
| Apr 11, 2018 | Class II | Z-2569-2018 | Employee error | There may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specification at a customer location. If the user experiences resistance between the FlowGate and an interfacing device, the device… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K212340 (Neuravi Limited, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K131492.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
FlowGate Balloon Guide Catheters are 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/K153729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153729: 8F FlowGate2 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/K153729
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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