510(k) · Cleared
ClearedFlipper Detachable Embolization Coils
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 Dec 20, 2006 as substantially equivalent to K993455 (Cook, Inc., 2000) and 1 other predicate after a 15-day review. Its family tree reaches back 5 generations to 1989. 1 later device descends from it.
- Decided
- Dec 20, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K891688 (1989). 15 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK891688 Coil and Coil Delivery SystemTarget Therapeutics · 1989
- 4 generations backK964367 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997
- 3 generations backK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
- 2 generations backK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
- 1 generation backK993455 Flipper Detachable Embolization CoilCook, Inc. · 2000
- This deviceK063619 Flipper Detachable Embolization CoilsCook, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK150964 MReye Flipper Detachable Embolization Coil and Delivery SystemCook Incorporated · 2015
Most influential descendants
Showing 1 of 1 · See all- K150964MReye Flipper Detachable Embolization Coil and Delivery SystemCook Incorporated · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K891688 | Coil and Coil Delivery System | Target Therapeutics | 1989 | — |
| −4 | K964367 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1997 | — |
| −3 | K972881 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1998 | — |
| −2 | K983483 | Vascular Occlusion System | Cordis Neurovascular, Inc. | 1999 | — |
| −1 | K993455 | Flipper Detachable Embolization Coil | Cook, Inc. | 2000 | — |
| 0 (this device) | K063619 | Flipper Detachable Embolization Coils | Cook, Inc. | 2006 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (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 |
|---|---|---|---|
| * | K993455 | Flipper Detachable Embolization CoilSummary page 1…Detachable Coil Delivery Wire are unscrewed. Substantial Equivalence: Cook Incorporated currently markets the Flipper® Detachable Embolization Coil (stainless steel-K993455) and the MReye® Embolization Coil (K052834), to which the Flipper® Detachable Embolization Coil (Inconel) is substantially equiv… | 2000 |
| * | K052834 | Mreye Embolization CoilSummary page 1…. Substantial Equivalence: Cook Incorporated currently markets the Flipper® Detachable Embolization Coil (stainless steel-K993455) and the MReye® Embolization Coil (K052834), to which the Flipper® Detachable Embolization Coil (Inconel) is substantially equivalent. The similar indications for use, ma… | 2005 |
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 |
|---|---|---|---|
| K150964 | MReye Flipper Detachable Embolization Coil and Delivery System | 2015 | 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 17 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K150964 (Cook Incorporated, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K993455.
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 arterial and venous embolization in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063619 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063619: Flipper Detachable Embolization Coils.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063619
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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