510(k) · Cleared
ClearedGelspheres Embolic Agent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocure, Inc. · HCG Device, Neurovascular Embolization
Cleared on Dec 16, 2002 as substantially equivalent to K010026 (Biosphere Medical, Inc., 2001) after a 90-day review. Its family tree reaches back 1 generation to 2001. 25 later devices descend from it.
- Decided
- Dec 16, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010026 (2001). 25 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK010026 Embogold MicrosphereBiosphere Medical, Inc. · 2001
- This deviceK023089 Gelspheres Embolic AgentBiocure, Inc. · 2002
- Descendant · cites it directly · 24 of its ownK033761 Gelspheres / Beadblock Compressible MicrospheresBiocompatibles UK Limited · 2004
- Descendant · cites it directly · 17 of its ownK042231 Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2004
- Descendant · 2 generations on · 11 of its ownK052742 Hepasphere MicrospheresBiosphere Medical, Inc. · 2006
- Descendant · 3 generations on · 8 of its ownK113266 Gel-Block Embolization PledgetsVascular Solutions, Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK073417 Embozene MicrospheresCelonova Biosciences, Inc. · 2008
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K033761Gelspheres / Beadblock Compressible MicrospheresBiocompatibles UK Limited · 2004 · cites it directly24descendants
- K042231Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2004 · cites it directly17descendants
- K052742Hepasphere MicrospheresBiosphere Medical, Inc. · 2006 · 2 generations on11descendants
- K113266Gel-Block Embolization PledgetsVascular Solutions, Inc. · 2012 · 3 generations on8descendants
- K073417Embozene MicrospheresCelonova Biosciences, Inc. · 2008 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010026 | Embogold Microsphere | Biosphere Medical, Inc. | 2001 | — |
| 0 (this device) | K023089 | Gelspheres Embolic Agent | Biocure, Inc. | 2002 | — |
| +1 | K033761 | Gelspheres / Beadblock Compressible Microspheres | Biocompatibles UK Limited | 2004 | — |
| +1 | K042231 | Gelspheres Microspheres and Bead Block Compressible Microspheres | Biocompatibles UK Limited | 2004 | — |
| +2 | K052742 | Hepasphere Microspheres | Biosphere Medical, Inc. | 2006 | — |
| +3 | K113266 | Gel-Block Embolization Pledgets | Vascular Solutions, Inc. | 2012 | — |
| +2 | K073417 | Embozene Microspheres | Celonova Biosciences, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2024 | 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? (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 | K891549 | Embospheres Microspheres Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K010026 | Embogold Microsphere | 2001 |
What descends from it? (25)
See all 253 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?
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 | — |
What is it indicated for?
GelSpheresm Embolic Agent is intended for embolization of hypervascular tumors and arteriovenous malformations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023089 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023089: Gelspheres Embolic Agent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023089
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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