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 Jan 3, 2013 as substantially equivalent to K992121 (Cook, Inc., 1999) after a 30-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it.
- Decided
- Jan 3, 2013
- Review
- 30 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K951256 (1995). 6 ancestors in all, the oldest K901337 (1990). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 2 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 1 generation backK992121 Embolization Coil SystemCook, Inc. · 1999
- This deviceK123712 Retracta Detachable Embolization CoilCook Incorporated · 2013
- Descendant · cites it directly · 2 of its ownK151676 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 3 of 3 · See all- K151676Retracta Detachable Embolization CoilCook Incorporated · 2015 · cites it directly2descendants
- K160219Hilal Embolization MicroCoilsCook Incorporated · 2016 · cites it directly0descendants
- K153778Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −2 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −1 | K992121 | Embolization Coil System | Cook, Inc. | 1999 | — |
| 0 (this device) | K123712 | Retracta Detachable Embolization Coil | Cook Incorporated | 2013 | — |
| +1 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K063619 | FDA’s K063619 is Flipper Detachable Embolization Coils Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2006 |
| * | K992121 | Embolization Coil SystemSummary page 1…stistnti~euiv~dlt the MReye Flipper® Detachable Embdlizatioxi Coils and the Detach 1HL and Detach, 18T Embolizatioitoils cleared under I10(k) nuimbers K663619 and K992121, respectively. .Comparison to Predicate Device: TM It has been demonstrated t… | 1999 |
What descends from it? (3)
3 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 18 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K151676 (Cook Incorporated, 2015) has gone furthest, with 2 descendants 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. 2013, 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/K123712 · printed Nov 3, 2026
Cite this page
510(k) Report. “K123712: Retracta Detachable Embolization Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123712
Report an extraction error
Are you the manufacturer?
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