510(k) · Cleared
ClearedEmbolization Coil System
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, 1999 as substantially equivalent to K940189 (Cook, Inc., 1994) and 4 other predicates after a 180-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.
- Decided
- Dec 20, 1999
- Review
- 180 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K951256 (1995). 5 ancestors in all, the oldest K901337 (1990). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 1 generation backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- This deviceK992121 Embolization Coil SystemCook, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK123712 Retracta Detachable Embolization CoilCook Incorporated · 2013
- Descendant · 2 generations on · 2 of its ownK151676 Retracta Detachable Embolization CoilCook Incorporated · 2015
- Descendant · 2 generations on · 0 of its ownK160219 Hilal Embolization MicroCoilsCook Incorporated · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK153778 Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated · 2016 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K123712Retracta Detachable Embolization CoilCook Incorporated · 2013 · cites it directly3descendants
- K151676Retracta Detachable Embolization CoilCook Incorporated · 2015 · 2 generations on2descendants
- K160219Hilal Embolization MicroCoilsCook Incorporated · 2016 · 2 generations on0descendants
- K153778Nester Embolization Coils, Tornado Embolization CoilsCook Incorporated · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −1 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| 0 (this device) | K992121 | Embolization Coil System | Cook, Inc. | 1999 | — |
| +1 | K123712 | Retracta Detachable Embolization Coil | Cook Incorporated | 2013 | — |
| +2 | K151676 | Retracta Detachable Embolization Coil | Cook Incorporated | 2015 | — |
| +2 | K160219 | Hilal Embolization MicroCoils | Cook Incorporated | 2016 | 1 |
| +2 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K940189 | Coil Positioner Set Our OCR of the scanned summary read K942189, FDA’s number for Crystal Ear (Crystal Care Intl., Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Embolization Coil Positioner Set”. | 1994 |
| * | K901337 | Hilal Embolization Microcoil (TM)Summary page 2…li size range of 2 to 20 mm. A push-button release mechanism is the method of deployment. Hilal Embolization Microcoils™ were reviewed as substantially equivalent under K901337 and are indicated for the embolization of arteriovenous malformations and other vascular lesions of the brain, spinal cord and sp… | 1990 |
| * | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Summary page 2…o 10 mm. Deployment is achieved by a wire guide which pushes the coil out of the catheter. The Guglielmi Detachable Coil® was reviewed as substantially equivalent under K951256 and K960705 and is indicated for embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae and… | 1995 |
| * | K960705 | Guglielmi Detachable CoilSummary page 2…loyment is achieved by a wire guide which pushes the coil out of the catheter. The Guglielmi Detachable Coil® was reviewed as substantially equivalent under K951256 and K960705 and is indicated for embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae and arterial ven… | 1996 |
| * | K955293 | Fibered Platinum Coil, .035 TypeSummary page 2…size range of 2 to 20 mm. The coil is deployed by electrolytic detachment from the wire guide. The Fibered Platinum Coil was reviewed as substantially equivalent under K955293 and is indicated for arterial and venous embolization in the peripheral vasculature. The device is 133 510(k) Pr… | 1996 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123712 | Retracta Detachable Embolization Coil | 2013 | 3 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K123712 (Cook Incorporated, 2013) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K940189.
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?
Arterial and venous embolization in the peripheral vasculature
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992121: Embolization Coil System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992121
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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