510(k) · Cleared
Recalled · 2009Concentric Balloon Guide Catheter, Model 90072
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 Jul 10, 2002 as substantially equivalent to K010954 (Concentric Medical, Inc., 2001) after a 30-day review. Its family tree reaches back 1 generation to 2001. 4 of the 188 devices in its family, counting itself, have a Class I recall. 186 later devices descend from it. It has been recalled once.
- Decided
- Jul 10, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010954 (2001). 186 later devices descend from it, 5 citing it directly. 4 of the 188 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- This deviceK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002
- Descendant · cites it directly · 106 of its ownK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- Descendant · 2 generations on · 105 of its ownK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 88 of its ownK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 86 of its ownK083125 Neuron Select Catheter Size 070Penumbra, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 61 of its ownK111380 Neuron Max SystemPenumbra, Inc. · 2011
Showing 5 of 186 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 186 · See all- K053491Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006 · cites it directly106descendants
- K070970Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · 2 generations on105descendants
- K082290Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · 3 generations on88descendants
- K083125Neuron Select Catheter Size 070Penumbra, Inc. · 2008 · 3 generations on86descendants
- K111380Neuron Max SystemPenumbra, Inc. · 2011 · 3 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| 0 (this device) | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | — |
| +1 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| +2 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| +3 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| +3 | K083125 | Neuron Select Catheter Size 070 | Penumbra, Inc. | 2008 | 1 |
| +3 | K111380 | Neuron Max System | Penumbra, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 9 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 9 | 0 |
| 2016 | 8 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 11 | 0 |
| 2020 | 15 | 2 |
| 2021 | 10 | 0 |
| 2022 | 14 | 1 |
| 2023 | 18 | 0 |
| 2024 | 22 | 1 |
| 2025 | 16 | 0 |
| 2026 | 21 | 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.
4 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K010954 | Concentric Balloon Guide Catheter, Model 90031Summary page 1…ry vascular occlusion during these and other angiographic procedures. 5.9 Product Description The Concentric Balloon Guide Catheter device, cleared under K010954, is a 9F coaxial lumen braided shaft, variable stiffness catheter with a radiopaque marker on the distal end. The bal… | 2001 |
| † | K003880 | Concentroc HD Guide Catheter, Models 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F)… | 2001 |
What descends from it? (186)
See all 1865 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | 2006 | 106 |
| K102657 | Concentric Balloon Guide Catheter | 2010 | 48 |
| K041151 | Kerberos Occluding Guide Catheter and Accessories | 2004 | 25 |
| K120781 | Cello Balloon Guide Catheter (6F), 950 MM and 1020 MM Length | 2012 | 4 |
| K112262 | Reflex Ballon Guide Catheter | 2011 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2009 | Not classified | Z-0899-2011 | Nonconforming Material/Component | Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K192804CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA…Medos International SARL · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242376Next Generation Access PlatformBalt USA, LLC · 2024 · 5 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K222743Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc. · 2022 · 8 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021899 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021899: Concentric Balloon Guide Catheter, Model 90072.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021899
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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