510(k) · Cleared
Recalled · Class II · 2018Concentric Balloon Guide Catheter, Model 90031
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 9, 2001 after a 193-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 188 devices in its family, counting itself, have a Class I recall. 187 later devices descend from it. It has been recalled once.
- Decided
- Oct 9, 2001
- Review
- 193 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1
- Predicates
- 0
187 later devices descend from it, 3 citing it directly. 4 of the 188 devices in this family, counting this one, have a Class I recall.
- This deviceK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001
- Descendant · cites it directly · 186 of its ownK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 106 of its ownK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- Descendant · 3 generations on · 105 of its ownK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- Descendant · 4 generations on · 88 of its ownK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 86 of its ownK083125 Neuron Select Catheter Size 070Penumbra, Inc. · 2008 · Recalled
Showing 5 of 187 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 187 · See all- K021899Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · cites it directly186descendants
- K053491Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006 · 2 generations on106descendants
- K070970Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · 3 generations on105descendants
- K082290Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · 4 generations on88descendants
- K083125Neuron Select Catheter Size 070Penumbra, Inc. · 2008 · 4 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | — |
| +1 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| +2 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| +3 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| +4 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| +4 | K083125 | Neuron Select Catheter Size 070 | Penumbra, Inc. | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (187)
See all 1873 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 13, 2018 | Class II | Z-0065-2020 | Labeling False and Misleading | Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging |
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 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242376Next Generation Access PlatformBalt USA, LLC · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. · 2020 · 8 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 · 9 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K021899 (Concentric Medical, Inc., 2002) has gone furthest, with 186 descendants of its own.
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) | — |
https://510kreport.com/device/K010954 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010954: Concentric Balloon Guide Catheter, Model 90031.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010954
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026