510(k) · Cleared
ClearedConcentric Guide Catheter, Models 90018, 90020
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 Mar 7, 2001 after a 155-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 8 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Mar 7, 2001
- Review
- 155 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly. 2 of the 8 devices in this family, counting this one, have a Class I recall.
- This deviceK003085 Concentric Guide Catheter, Models 90018, 90020Concentric Medical, Inc. · 2001
- Descendant · cites it directly · 6 of its ownK070770 Gore Balloon SheathW. L. Gore & Associates, Inc. · 2007
- Descendant · 2 generations on · 5 of its ownK083300 Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009
- Descendant · 3 generations on · 2 of its ownK143072 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015
- Descendant · 4 generations on · 1 of its ownK153485 ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · Recalled (Class I)
- Descendant · 5 generations on · 0 of its ownK230402 ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · Recalled (Class I)
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K070770Gore Balloon SheathW. L. Gore & Associates, Inc. · 2007 · cites it directly6descendants
- K083300Gore Flow Reversal SystemW. L. Gore & Associates, Inc. · 2009 · 2 generations on5descendants
- K143072ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2015 · 3 generations on2descendants
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 4 generations on1descendant
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003085 | Concentric Guide Catheter, Models 90018, 90020 | Concentric Medical, Inc. | 2001 | — |
| +1 | K070770 | Gore Balloon Sheath | W. L. Gore & Associates, Inc. | 2007 | — |
| +2 | K083300 | Gore Flow Reversal System | W. L. Gore & Associates, Inc. | 2009 | — |
| +3 | K143072 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2015 | — |
| +4 | K153485 | ENROUTE Transcarotid Neuroprotection System | Silk Road Medical, Inc. | 2016 | Class I |
| +5 | K230402 | ENROUTE® Transcarotid Neuroprotection System | Silk Road Medical | 2023 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2023 | 1 | 1 |
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.
2 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? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070770 | Gore Balloon Sheath | 2007 | 6 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
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.
- K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K070770 (W. L. Gore & Associates, Inc., 2007) has gone furthest, with 6 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/K003085 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003085: Concentric Guide Catheter, Models 90018, 90020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003085
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026