510(k) · Cleared
ClearedModified Concentric Retriever, Model 90038
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 Aug 11, 2004 as substantially equivalent to K003410 (Concentric Medical, Inc., 2001) and 1 other predicate after a 141-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Aug 11, 2004
- Review
- 141 days
- Class
- Class II
- Product code
- DQY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003410 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 1 generation backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- This deviceK040745 Modified Concentric Retriever, Model 90038Concentric Medical, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK051838 Modified Concentric Retriever, Model 90039Concentric Medical, Inc. · 2005
Most influential descendants
Showing 1 of 1 · See all- K051838Modified Concentric Retriever, Model 90039Concentric Medical, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −1 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| 0 (this device) | K040745 | Modified Concentric Retriever, Model 90038 | Concentric Medical, Inc. | 2004 | — |
| +1 | K051838 | Modified Concentric Retriever, Model 90039 | Concentric Medical, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (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 |
|---|---|---|---|
| * | K003410 | Concentric Retriever, Model 90030Summary page 1…systems. during interventional radiological procedures in the neuro, peripheral and coronary vascular Predicate Devices Concentric Retriever K003410, K030476 Manufactured by Concentric Medical, Inc. Device Description… | 2001 |
| * | K030476 | Modified Concentric Retriever, Model 90037Summary page 1…during interventional radiological procedures in the neuro, peripheral and coronary vascular Predicate Devices Concentric Retriever K003410, K030476 Manufactured by Concentric Medical, Inc. Device Description… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051838 | Modified Concentric Retriever, Model 90039 | 2005 | 0 |
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 3 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K051838 (Concentric Medical, Inc., 2005) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K003410.
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 Modified Concentric Retriever is indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040745 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040745: Modified Concentric Retriever, Model 90038.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040745
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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