510(k) · Cleared
ClearedOptima Coil System (OptiOne Coil System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Balt USA, LLC · HCG Device, Neurovascular Embolization
Cleared on Jan 27, 2026 as substantially equivalent to K252700 (Balt USA, LLC, 2025) after a 29-day review. Its family tree reaches back 27 generations to 1995.
- Decided
- Jan 27, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 27 generations to K951256 (1995). 69 ancestors in all, the oldest K860840 (1986). No later device cites it as a predicate yet.
- Root · 27 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 23 generations between
- 3 generations backK223386 Optima Coil SystemBalt USA, LLC · 2022 · Recalled
- 2 generations backK242582 Optima Coil System (OptiBlock Line Extension)Balt USA, LLC · 2024
- 1 generation backK252700 Optima Coil System (Optima Packing Coil System)Balt USA, LLC · 2025
- This deviceK254221 Optima Coil System (OptiOne Coil System)Balt USA, LLC · 2026
Show all 27 generations
- Root · 27 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 26 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 25 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 24 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 23 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 22 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 21 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 20 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 19 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 18 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 17 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 16 generations backK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
- 15 generations backK080666 Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008
- 14 generations backK112226 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2011
- 13 generations backK113457 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2011
- 12 generations backK120908 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2012
- 11 generations backK123338 Barricade Embolization Coil SystemBlockade Medical · 2013
- 10 generations backK131475 Barricade Embolization Coil SystemBlockade Medical · 2013
- 9 generations backK132482 Barricade Embolization Coil SystemBlockade Medical · 2013
- 8 generations backK140104 Barricade Embolization Coil SystemBlockade Medical · 2014
- 7 generations backK142513 Barricade Embolization Coil SystemBlockade Medical · 2014
- 6 generations backK151760 Barricade Embolization Coil SystemBlockade Medical · 2015
- 5 generations backK172390 Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa) · 2018 · Recalled
- 4 generations backK200030 Optima Coil SystemBalt USA, LLC · 2020 · Recalled
- 3 generations backK223386 Optima Coil SystemBalt USA, LLC · 2022 · Recalled
- 2 generations backK242582 Optima Coil System (OptiBlock Line Extension)Balt USA, LLC · 2024
- 1 generation backK252700 Optima Coil System (Optima Packing Coil System)Balt USA, LLC · 2025
- This deviceK254221 Optima Coil System (OptiOne Coil System)Balt USA, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −26 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −25 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −24 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −23 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −22 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −21 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −20 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −19 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −18 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| −17 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| −16 | K070656 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2007 | — |
| −15 | K080666 | Hydrosoft and Hydrosoft Plus Embolization Coil Systems | MicroVention, Inc. | 2008 | — |
| −14 | K112226 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2011 | — |
| −13 | K113457 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2011 | — |
| −12 | K120908 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2012 | — |
| −11 | K123338 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
| −10 | K131475 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
| −9 | K132482 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
| −8 | K140104 | Barricade Embolization Coil System | Blockade Medical | 2014 | — |
| −7 | K142513 | Barricade Embolization Coil System | Blockade Medical | 2014 | — |
| −6 | K151760 | Barricade Embolization Coil System | Blockade Medical | 2015 | — |
| −5 | K172390 | Optima Coil System | Blockade Medical, LLC (D.B.A. Balt Usa) | 2018 | 4 |
| −4 | K200030 | Optima Coil System | Balt USA, LLC | 2020 | 5 |
| −3 | K223386 | Optima Coil System | Balt USA, LLC | 2022 | 1 |
| −2 | K242582 | Optima Coil System (OptiBlock Line Extension) | Balt USA, LLC | 2024 | — |
| −1 | K252700 | Optima Coil System (Optima Packing Coil System) | Balt USA, LLC | 2025 | — |
| 0 (this device) | K254221 | Optima Coil System (OptiOne Coil System) | Balt USA, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 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 HCG? 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? (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 |
|---|---|---|---|
| * | K252700 | Optima Coil System (Optima Packing Coil System)Summary page 5…ular Embolization; Device, Vascular, for Promoting Embolization Device Classification: Class II Predicate Device: Optima Coil System, 510(k): K252700 Device Description: The Optima Coil System is a series of specialized coils that are inserted into the vasculature under… | 2025 |
| † | K200030 | Optima Coil System | 2020 |
| † | K242582 | Optima Coil System (OptiBlock Line Extension) | 2024 |
| † | K223386 | Optima Coil System | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 16 of the 69 ancestors have a recall of any class.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Optima Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Optima Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations 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/K254221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254221: Optima Coil System (OptiOne 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/K254221
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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