510(k) · Cleared
ClearedLC Bead LUMI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocompatibles UK, Ltd. · KRD Device, Vascular, For Promoting Embolization
Cleared on Dec 11, 2015 as substantially equivalent to K083091 (Biocompatibles UK Limited, 2008) after a 130-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.
- Decided
- Dec 11, 2015
- Review
- 130 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010026 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK010026 Embogold MicrosphereBiosphere Medical, Inc. · 2001
- 4 generations backK023089 Gelspheres Embolic AgentBiocure, Inc. · 2002
- 3 generations backK033761 Gelspheres / Beadblock Compressible MicrospheresBiocompatibles UK Limited · 2004
- 2 generations backK042231 Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2004
- 1 generation backK083091 LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2008
- This deviceK152157 LC Bead LUMIBiocompatibles UK, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK162373 LC Bead LUMIBiocompatibles UK Limited · 2016
Most influential descendants
Showing 1 of 1 · See all- K162373LC Bead LUMIBiocompatibles UK Limited · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010026 | Embogold Microsphere | Biosphere Medical, Inc. | 2001 | — |
| −4 | K023089 | Gelspheres Embolic Agent | Biocure, Inc. | 2002 | — |
| −3 | K033761 | Gelspheres / Beadblock Compressible Microspheres | Biocompatibles UK Limited | 2004 | — |
| −2 | K042231 | Gelspheres Microspheres and Bead Block Compressible Microspheres | Biocompatibles UK Limited | 2004 | — |
| −1 | K083091 | LC Bead Microspheres, Bead Block Compressible Microspheres | Biocompatibles UK Limited | 2008 | — |
| 0 (this device) | K152157 | LC Bead LUMI | Biocompatibles UK, Ltd. | 2015 | — |
| +1 | K162373 | LC Bead LUMI | Biocompatibles UK Limited | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K083091 | LC Bead Microspheres, Bead Block Compressible MicrospheresSummary page 4…ization Device Classification Name: Vascular Embolization Device (21 CFR 870.3300) Regulatory Class: II Product Code: KRD 5.3 Predicate Device LC BeadTM Microspheres K083091 LC Bead Microspheres / Bead Block Compressible Microspheres Manufacturer: Biocompatibles UK Ltd. CFR 870.3300 Product code: KRD… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162373 | LC Bead LUMI | 2016 | 0 |
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 14 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K162373 (Biocompatibles UK Limited, 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K083091.
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. 2015, 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 LUMI are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152157: LC Bead LUMI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152157
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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