510(k) · Cleared
ClearedLC Bead Microspheres, Bead Block Compressible Microspheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocompatibles UK Limited · KRD Device, Vascular, For Promoting Embolization
Cleared on Dec 24, 2008 as substantially equivalent to K023089 (Biocure, Inc., 2002) and 2 other predicates after a 68-day review. Its family tree reaches back 4 generations to 2001. 4 later devices descend from it.
- Decided
- Dec 24, 2008
- Review
- 68 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K010026 (2001). 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK010026 Embogold MicrosphereBiosphere Medical, Inc. · 2001
- 3 generations backK023089 Gelspheres Embolic AgentBiocure, Inc. · 2002
- 2 generations backK033761 Gelspheres / Beadblock Compressible MicrospheresBiocompatibles UK Limited · 2004
- 1 generation backK042231 Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2004
- This deviceK083091 LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2008
- Descendant · cites it directly · 1 of its ownK152157 LC Bead LUMIBiocompatibles UK, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK162373 LC Bead LUMIBiocompatibles UK Limited · 2016
- Descendant · cites it directly · 0 of its ownK150958 LifePearl MicroshperesMicroVention, Inc. · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK094018 LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2010
Most influential descendants
Showing 4 of 4 · See all- K152157LC Bead LUMIBiocompatibles UK, Ltd. · 2015 · cites it directly1descendant
- K162373LC Bead LUMIBiocompatibles UK Limited · 2016 · 2 generations on0descendants
- K150958LifePearl MicroshperesMicroVention, Inc. · 2015 · cites it directly0descendants
- K094018LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010026 | Embogold Microsphere | Biosphere Medical, Inc. | 2001 | — |
| −3 | K023089 | Gelspheres Embolic Agent | Biocure, Inc. | 2002 | — |
| −2 | K033761 | Gelspheres / Beadblock Compressible Microspheres | Biocompatibles UK Limited | 2004 | — |
| −1 | K042231 | Gelspheres Microspheres and Bead Block Compressible Microspheres | Biocompatibles UK Limited | 2004 | — |
| 0 (this device) | K083091 | LC Bead Microspheres, Bead Block Compressible Microspheres | Biocompatibles UK Limited | 2008 | — |
| +1 | K152157 | LC Bead LUMI | Biocompatibles UK, Ltd. | 2015 | — |
| +2 | K162373 | LC Bead LUMI | Biocompatibles UK Limited | 2016 | — |
| +1 | K150958 | LifePearl Microshperes | MicroVention, Inc. | 2015 | 1 |
| +1 | K094018 | LC Bead Microspheres, Bead Block Compressible Microspheres | Biocompatibles UK Limited | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 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 KRD? 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 KRD device
- #1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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…32732 Contact: Dr. Alistair Taylor 510(k) Numbers and Product Codes of equivalent devices. BioCure, Inc, GeiSpheres Microspheres 510OK Number: #K023089 Product Code: HCGIKRD CFR Section: 882.5950 Biocompatibles UK Ltd. GeiSpheres Microspheres… | 2002 |
| * | K033761 | Gelspheres / Beadblock Compressible MicrospheresSummary page 1…IKRD CFR Section: 882.5950 Biocompatibles UK Ltd. GeiSpheres Microspheres Bead BlockTM Compressible Microspheres 510OK Number: #K033761 Product Code: HCGIKRD CFR Section: 882.5950 Biocompatibles UK Ltd. GeiSpheres Microspheres… | 2004 |
| * | K042231 | Gelspheres Microspheres and Bead Block Compressible MicrospheresSummary page 1…IKRD CFR Section: 882.5950 Biocompatibles UK Ltd. GeiSpheres Microspheres Bead BlockTM Compressible Microspheres 510OK Number: #K042231 Product Code: HCG CFR Section: 870.3300 Biocompatibles UK Ltd… | 2004 |
What descends from it? (4)
3 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 7 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K152157 (Biocompatibles UK, Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K023089.
How does its category compare?
All KRD devicesKRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KRD
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRD
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRD
1,572in 2025
MAUDE reports naming product code KRD, 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 | 2 | — | 0 | 21 |
| 2008 | 5 | 84 | 0 | 14 |
| 2009 | 4 | 27 | 0 | 40 |
| 2010 | 3 | 150 | 1 | 61 |
| 2011 | 5 | 36 | 0 | 102 |
| 2012 | 8 | 30 | 0 | 137 |
| 2013 | 11 | 33 | 1 | 244 |
| 2014 | 7 | 134 | 0 | 159 |
| 2015 | 11 | 130 | 0 | 337 |
| 2016 | 4 | 164 | 0 | 437 |
| 2017 | 4 | 89 | 0 | 736 |
| 2018 | 4 | 62 | 0 | 1,066 |
| 2019 | 6 | 178 | 0 | 1,185 |
| 2020 | 4 | 137 | 0 | 1,167 |
| 2021 | 3 | 134 | 0 | 1,444 |
| 2022 | 8 | 175 | 0 | 1,498 |
| 2023 | 2 | — | 1 | 1,371 |
| 2024 | 6 | 70 | 1 | 1,535 |
| 2025 | 9 | 60 | 0 | 1,572 |
| 2026 | 7 | 70 | 1 | — |
What is it indicated for?
LC Bead 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/K083091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083091: LC Bead Microspheres, Bead Block Compressible Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083091
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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