510(k) · Cleared
ClearedRetracta Detachable Embolization Coil
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 Jul 22, 2015 as substantially equivalent to K123712 (Cook Incorporated, 2013) after a 30-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Jul 22, 2015
- Review
- 30 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K951256 (1995). 7 ancestors in all, the oldest K901337 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 3 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 2 generations backK992121 Embolization Coil SystemCook, Inc. · 1999
- 1 generation backK123712 Retracta Detachable Embolization CoilCook Incorporated · 2013
- This deviceK151676 Retracta Detachable Embolization CoilCook Incorporated · 2015
- Descendant · cites it directly · 0 of its ownK160219 Hilal Embolization MicroCoilsCook Incorporated · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK153778 Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated · 2016 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −3 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −2 | K992121 | Embolization Coil System | Cook, Inc. | 1999 | — |
| −1 | K123712 | Retracta Detachable Embolization Coil | Cook Incorporated | 2013 | — |
| 0 (this device) | K151676 | Retracta Detachable Embolization Coil | Cook Incorporated | 2015 | — |
| +1 | K160219 | Hilal Embolization MicroCoils | Cook Incorporated | 2016 | 1 |
| +1 | K153778 | Nester Embolization Coils, Tornado Embolization Coils | Cook Incorporated | 2016 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K123712 | Retracta Detachable Embolization CoilSummary page 4…ice: The device subject of this submission is substantially equivalent to the predicate device, the Retracta® Detachable Embolization Coils, cleared under 510(k) number K123712. Comparison to Predicate Device: It has been demonstrated that the Retracta Detachable Embolization Coil is comparable to the p… | 2013 |
What descends from it? (2)
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K160219 (Cook Incorporated, 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K123712.
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?
The Retracta Detachable Embolization Coil is intended for arterial and venous embolization in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151676 · printed Nov 5, 2026
Cite this page
510(k) Report. “K151676: Retracta Detachable 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/K151676
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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