510(k) · Cleared
ClearedMreye Embolization Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Nov 23, 2005 after a 48-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Nov 23, 2005
- Review
- 48 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK052834 Mreye Embolization CoilCook, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK090624 Cook Mreye Embolization CoilsCook, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK063619 Flipper Detachable Embolization CoilsCook, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK150964 MReye Flipper Detachable Embolization Coil and Delivery SystemCook Incorporated · 2015
- Descendant · 2 generations on · 0 of its ownK150931 MReye Embolization CoilsCook Incorporated · 2015
Most influential descendants
Showing 4 of 4 · See all- K090624Cook Mreye Embolization CoilsCook, Inc. · 2009 · cites it directly1descendant
- K063619Flipper Detachable Embolization CoilsCook, Inc. · 2006 · cites it directly1descendant
- K150964MReye Flipper Detachable Embolization Coil and Delivery SystemCook Incorporated · 2015 · 2 generations on0descendants
- K150931MReye Embolization CoilsCook Incorporated · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052834 | Mreye Embolization Coil | Cook, Inc. | 2005 | — |
| +1 | K090624 | Cook Mreye Embolization Coils | Cook, Inc. | 2009 | — |
| +1 | K063619 | Flipper Detachable Embolization Coils | Cook, Inc. | 2006 | — |
| +2 | K150964 | MReye Flipper Detachable Embolization Coil and Delivery System | Cook Incorporated | 2015 | — |
| +2 | K150931 | MReye Embolization Coils | Cook Incorporated | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 2 | 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 KRD? 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 KRD device
- #1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 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 |
|---|---|---|---|
| * | — | Cook Embolization Coil Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K090624 (Cook, Inc., 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KRD devicesKRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KRD
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRD
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRD
1,572in 2025
MAUDE reports naming product code KRD, 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 | 2 | — | 0 | 21 |
| 2008 | 5 | 84 | 0 | 14 |
| 2009 | 4 | 27 | 0 | 40 |
| 2010 | 3 | 150 | 1 | 61 |
| 2011 | 5 | 36 | 0 | 102 |
| 2012 | 8 | 30 | 0 | 137 |
| 2013 | 11 | 33 | 1 | 244 |
| 2014 | 7 | 134 | 0 | 159 |
| 2015 | 11 | 130 | 0 | 337 |
| 2016 | 4 | 164 | 0 | 437 |
| 2017 | 4 | 89 | 0 | 736 |
| 2018 | 4 | 62 | 0 | 1,066 |
| 2019 | 6 | 178 | 0 | 1,185 |
| 2020 | 4 | 137 | 0 | 1,167 |
| 2021 | 3 | 134 | 0 | 1,444 |
| 2022 | 8 | 175 | 0 | 1,498 |
| 2023 | 2 | — | 1 | 1,371 |
| 2024 | 6 | 70 | 1 | 1,535 |
| 2025 | 9 | 60 | 0 | 1,572 |
| 2026 | 7 | 70 | 1 | — |
What is it indicated for?
Used for peripheral arterial and venous vessel embolization procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052834 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052834: Mreye Embolization Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052834
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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