510(k) · Cleared
ClearedMReye Flipper Detachable Embolization Coil and Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · KRD Device, Vascular, For Promoting Embolization
Cleared on Dec 18, 2015 as substantially equivalent to K063619 (Cook, Inc., 2006) after a 252-day review. Its family tree reaches back 6 generations to 1989.
- Decided
- Dec 18, 2015
- Review
- 252 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K891688 (1989). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK891688 Coil and Coil Delivery SystemTarget Therapeutics · 1989
- 5 generations backK964367 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997
- 4 generations backK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
- 3 generations backK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
- 2 generations backK993455 Flipper Detachable Embolization CoilCook, Inc. · 2000
- 1 generation backK063619 Flipper Detachable Embolization CoilsCook, Inc. · 2006
- This deviceK150964 MReye Flipper Detachable Embolization Coil and Delivery SystemCook Incorporated · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K891688 | Coil and Coil Delivery System | Target Therapeutics | 1989 | — |
| −5 | K964367 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1997 | — |
| −4 | K972881 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1998 | — |
| −3 | K983483 | Vascular Occlusion System | Cordis Neurovascular, Inc. | 1999 | — |
| −2 | K993455 | Flipper Detachable Embolization Coil | Cook, Inc. | 2000 | — |
| −1 | K063619 | Flipper Detachable Embolization Coils | Cook, Inc. | 2006 | — |
| 0 (this device) | K150964 | MReye Flipper Detachable Embolization Coil and Delivery System | Cook Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 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 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 |
|---|---|---|---|
| * | K063619 | Flipper Detachable Embolization CoilsSummary page 4…e device subject of this submission is believed to warrant a determination of substantial equivalence to the predicate device, the Flipper® Detachable Embolization Coil (K063619). IV.DEVICE DESCRIPTION The MReye® Flipper® Detachable Embolization Coil and Delivery System consists of a fibered detachable em… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 2 of the 16 ancestors have a recall of any class.
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. 2015, this device’s year, is highlighted.
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?
MReye Flipper Detachable Embolization Coils are intended for arterial and venous embolization in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150964 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150964: MReye Flipper Detachable Embolization Coil and Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150964
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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