510(k) · Cleared
ClearedGelspheres Microspheres and Bead Block Compressible Microspheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocompatibles UK Limited · HCG Device, Neurovascular Embolization
Cleared on Nov 12, 2004 as substantially equivalent to K023089 (Biocure, Inc., 2002) and 1 other predicate after an 87-day review. Its family tree reaches back 3 generations to 2001. 17 later devices descend from it.
- Decided
- Nov 12, 2004
- Review
- 87 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010026 (2001). 17 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK010026 Embogold MicrosphereBiosphere Medical, Inc. · 2001
- 2 generations backK023089 Gelspheres Embolic AgentBiocure, Inc. · 2002
- 1 generation backK033761 Gelspheres / Beadblock Compressible MicrospheresBiocompatibles UK Limited · 2004
- This deviceK042231 Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2004
- Descendant · cites it directly · 11 of its ownK052742 Hepasphere MicrospheresBiosphere Medical, Inc. · 2006
- Descendant · 2 generations on · 8 of its ownK113266 Gel-Block Embolization PledgetsVascular Solutions, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK083091 LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2008
- Descendant · 3 generations on · 2 of its ownK143038 Gel-Block 10X embolization pledgetsVascular Solutions, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK133237 Gel-Bead Embolization SpheresVascular Solutions, Inc. · 2014
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K052742Hepasphere MicrospheresBiosphere Medical, Inc. · 2006 · cites it directly11descendants
- K113266Gel-Block Embolization PledgetsVascular Solutions, Inc. · 2012 · 2 generations on8descendants
- K083091LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2008 · cites it directly4descendants
- K143038Gel-Block 10X embolization pledgetsVascular Solutions, Inc. · 2014 · 3 generations on2descendants
- K133237Gel-Bead Embolization SpheresVascular Solutions, Inc. · 2014 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010026 | Embogold Microsphere | Biosphere Medical, Inc. | 2001 | — |
| −2 | K023089 | Gelspheres Embolic Agent | Biocure, Inc. | 2002 | — |
| −1 | K033761 | Gelspheres / Beadblock Compressible Microspheres | Biocompatibles UK Limited | 2004 | — |
| 0 (this device) | K042231 | Gelspheres Microspheres and Bead Block Compressible Microspheres | Biocompatibles UK Limited | 2004 | — |
| +1 | K052742 | Hepasphere Microspheres | Biosphere Medical, Inc. | 2006 | — |
| +2 | K113266 | Gel-Block Embolization Pledgets | Vascular Solutions, Inc. | 2012 | — |
| +1 | K083091 | LC Bead Microspheres, Bead Block Compressible Microspheres | Biocompatibles UK Limited | 2008 | — |
| +3 | K143038 | Gel-Block 10X embolization pledgets | Vascular Solutions, Inc. | 2014 | — |
| +3 | K133237 | Gel-Bead Embolization Spheres | Vascular Solutions, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 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 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023089 | Gelspheres Embolic AgentSummary page 1…252732732 Contact: Dr. Alistair Taylor 510(k) Numbers and Product Codes of equivalent devices. Biocure, Inc, GelSphereSTM Microspheres 510OK Number: #K023089 Product Code: HOG CFR Section: 882.5950 Biocompatibles UK Ltd. GelSpheres TM Microspheres Bead Blo… | 2002 |
| * | K033761 | Gelspheres / Beadblock Compressible MicrospheresSummary page 1…ct Code: HOG CFR Section: 882.5950 Biocompatibles UK Ltd. GelSpheres TM Microspheres Bead Block TM Compressible Microspheres 510K Number: #K033761 Product Code: HOG CFR Section: 882.5950 Indications for Use and Intended Population "GelSphereSTMl/Bead BlockTM Com… | 2004 |
What descends from it? (17)
See all 173 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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K052742 (Biosphere Medical, Inc., 2006) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K023089.
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?
"GelSpheresTM Microspheres & Bead BlockTM Compressible Microspheres is intended for embolization of hypervascular tumors and arteriovenous malformations."
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042231 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042231: Gelspheres Microspheres and Bead Block Compressible Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042231
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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