510(k) · Cleared
Recalled · 2008Hilal Embolization Microcoil (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · HCG Device, Neurovascular Embolization
Cleared on Nov 13, 1990 after a 236-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 140 devices in its family, counting itself, has a Class I recall. 139 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 13, 1990
- Review
- 236 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 2
- Predicates
- 0
139 later devices descend from it, 7 citing it directly. 1 of the 140 devices in this family, counting this one, has a Class I recall.
- This deviceK901337 Hilal Embolization Microcoil (TM)Cook, Inc. · 1990
- Descendant · cites it directly · 80 of its ownK964367 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997
- Descendant · cites it directly · 79 of its ownK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
- Descendant · cites it directly · 78 of its ownK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
- Descendant · cites it directly · 69 of its ownK993418 Fibered GDC-18 Vortx Shape Guglielmi Detachable CoilBoston Scientific, Target · 2000 · Recalled
- Descendant · 2 generations on · 67 of its ownK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
Showing 5 of 139 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…6 generations on · 2022
Most influential descendants
Showing 5 of 139 · See all- K964367Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997 · cites it directly80descendants
- K972881Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998 · cites it directly79descendants
- K983483Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999 · cites it directly78descendants
- K993418Fibered GDC-18 Vortx Shape Guglielmi Detachable CoilBoston Scientific, Target · 2000 · cites it directly69descendants
- K033836Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003 · 2 generations on67descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K901337 | Hilal Embolization Microcoil (TM) | Cook, Inc. | 1990 | — |
| +1 | K964367 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1997 | — |
| +1 | K972881 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1998 | — |
| +1 | K983483 | Vascular Occlusion System | Cordis Neurovascular, Inc. | 1999 | — |
| +1 | K993418 | Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil | Boston Scientific, Target | 2000 | 1 |
| +2 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 8 | 0 |
| 2009 | 10 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 7 | 0 |
| 2013 | 14 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 1 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 HCG device
- #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (139)
See all 1397 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K964367 | Ces Vascular Occlusion System | 1997 | 80 |
| K972881 | Ces Vascular Occlusion System | 1998 | 79 |
| K983483 | Vascular Occlusion System | 1999 | 78 |
| K993418 | Fibered GDC-18 Vortx Shape Guglielmi Detachable Coil | 2000 | 69 |
| K993455 | Flipper Detachable Embolization Coil | 2000 | 41 |
| K033372 | Sapphire Detachable Fibered Coil System, Helix Fibered, Cyclone, Multiple Models | 2004 | 29 |
| K992121 | Embolization Coil System | 1999 | 4 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 8, 2008 | Not classified | Z-2058-2008 | Labeling Change Control | The product length is declared incorrectly in mm when the unit of measurement should be cm. |
| May 8, 2008 | Not classified | Z-2057-2008 | Labeling Change Control | The product length is declared incorrectly in mm when the unit of measurement should be cm. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft…Medos International SARL · 2022 · 6 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K964367 (Cordis Neurovascular, Inc., 1997) has gone furthest, with 80 descendants of its own.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HCG
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HCG
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HCG
537in 2025
MAUDE reports naming product code HCG, 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 | 8 | 50 | 1 | 326 |
| 2008 | 9 | 71 | 3 | 730 |
| 2009 | 7 | 48 | 0 | 821 |
| 2010 | 8 | 72 | 2 | 851 |
| 2011 | 9 | 78 | 1 | 894 |
| 2012 | 7 | 30 | 0 | 1,146 |
| 2013 | 7 | 67 | 2 | 1,103 |
| 2014 | 5 | 66 | 4 | 1,729 |
| 2015 | 5 | 60 | 0 | 1,598 |
| 2016 | 7 | 37 | 0 | 1,991 |
| 2017 | 5 | 97 | 0 | 2,494 |
| 2018 | 4 | 173 | 0 | 2,058 |
| 2019 | 1 | — | 0 | 1,763 |
| 2020 | 2 | — | 0 | 1,754 |
| 2021 | 5 | 103 | 0 | 2,268 |
| 2022 | 3 | 114 | 2 | 663 |
| 2023 | 2 | — | 0 | 568 |
| 2024 | 4 | 49 | 1 | 552 |
| 2025 | 3 | 107 | 1 (1) | 537 |
| 2026 | 4 | 30 | 1 | — |
https://510kreport.com/device/K901337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K901337: Hilal Embolization Microcoil (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901337
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026