510(k) · Cleared
ClearedHelix Shaped Coils with Dacron Fibers, Modified
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Target Therapeutics · HCG Device, Neurovascular Embolization
Cleared on Nov 8, 1991 after a 106-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 81 devices in its family, counting itself, has a Class I recall. 80 later devices descend from it.
- Decided
- Nov 8, 1991
- Review
- 106 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 0
80 later devices descend from it, 1 citing it directly. 1 of the 81 devices in this family, counting this one, has a Class I recall.
- This deviceK913312 Helix Shaped Coils with Dacron Fibers, ModifiedTarget Therapeutics · 1991
- Descendant · cites it directly · 79 of its ownK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
- Descendant · 2 generations on · 78 of its ownK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
- Descendant · 3 generations on · 41 of its ownK993455 Flipper Detachable Embolization CoilCook, Inc. · 2000
- Descendant · 4 generations on · 38 of its ownK031810 Amplatzer Vascular PlugAga Medical Corp. · 2003 · Recalled
- Descendant · 3 generations on · 32 of its ownK071962 Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil…Cordis Neurovascular, Inc. · 2007
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…7 generations on · 2022
Most influential descendants
Showing 5 of 80 · See all- K972881Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998 · cites it directly79descendants
- K983483Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999 · 2 generations on78descendants
- K993455Flipper Detachable Embolization CoilCook, Inc. · 2000 · 3 generations on41descendants
- K031810Amplatzer Vascular PlugAga Medical Corp. · 2003 · 4 generations on38descendants
- K071962Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher)Cordis Neurovascular, Inc. · 2007 · 3 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913312 | Helix Shaped Coils with Dacron Fibers, Modified | Target Therapeutics | 1991 | — |
| +1 | K972881 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1998 | — |
| +2 | K983483 | Vascular Occlusion System | Cordis Neurovascular, Inc. | 1999 | — |
| +3 | K993455 | Flipper Detachable Embolization Coil | Cook, Inc. | 2000 | — |
| +4 | K031810 | Amplatzer Vascular Plug | Aga Medical Corp. | 2003 | 1 |
| +3 | K071962 | Vascular Occlusion System (Trufill Pushable Coils and Trupush Coil Pusher) | Cordis Neurovascular, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 1 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 7 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (80)
See all 801 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972881 | Ces Vascular Occlusion System | 1998 | 79 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 7 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K972881 (Cordis Neurovascular, Inc., 1998) has gone furthest, with 79 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/K913312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913312: Helix Shaped Coils with Dacron Fibers, Modified.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913312
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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