510(k) Report

510(k) · Cleared

Cleared

LC Bead Microspheres, Bead Block Compressible Microspheres

K094018510(k) SpecialCleared Apr 16, 2010108-day reviewClass II21 CFR 882.5950

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biocompatibles UK Limited · HCG Device, Neurovascular Embolization

Cleared on Apr 16, 2010 as substantially equivalent to K033761 (Biocompatibles UK Limited, 2004) and 2 other predicates after a 108-day review. Its family tree reaches back 5 generations to 2001.

Decided
Apr 16, 2010
Review
108 days
Class
Class II
Product code
HCG
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K010026 (2001). No later device cites it as a predicate yet.

K010026 · Embogold Microsphere · Biosphere Medical, Inc. · 2001K023089 · Gelspheres Embolic Agent · Biocure, Inc. · 2002K033761 · Gelspheres / Beadblock Compressible Microspheres · Biocompatibles UK Limited · 2004K042231 · Gelspheres Microspheres and Bead Block Compressible Microspheres · Biocompatibles UK Limited · 2004K083091 · LC Bead Microspheres, Bead Block Compressible Microspheres · Biocompatibles UK Limited · 20082000200220042006200820102012
K083091 · LC Bead Microspheres, Bead Block Compressible Microspheres · Biocompatibles UK Limited · 2008K042231 · Gelspheres Microspheres and Bead Block Compressible Microspheres · Biocompatibles UK Limited · 2004K033761 · Gelspheres / Beadblock Compressible Microspheres · Biocompatibles UK Limited · 2004K023089 · Gelspheres Embolic Agent · Biocure, Inc. · 2002K010026 · Embogold Microsphere · Biosphere Medical, Inc. · 2001−50
  1. Root · 5 generations backK010026 Embogold MicrosphereBiosphere Medical, Inc. · 2001
  2. 4 generations backK023089 Gelspheres Embolic AgentBiocure, Inc. · 2002
  3. 3 generations backK033761 Gelspheres / Beadblock Compressible MicrospheresBiocompatibles UK Limited · 2004
  4. 2 generations backK042231 Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2004
  5. 1 generation backK083091 LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2008
  6. This deviceK094018 LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K010026Embogold MicrosphereBiosphere Medical, Inc.2001—
−4K023089Gelspheres Embolic AgentBiocure, Inc.2002—
−3K033761Gelspheres / Beadblock Compressible MicrospheresBiocompatibles UK Limited2004—
−2K042231Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited2004—
−1K083091LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited2008—
0 (this device)K094018LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited2010—
FIG. 1 — Lineage of K094018, 2001–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K033761Gelspheres / Beadblock Compressible Microspheres
Summary page 1
…rs and Product Codes of equivalent devices. Biocompatibles UK Ltd GelSpheres Microspheres Bead Block Compressible Microspheres 510OK Number: K033761 Product Code: HCG/KRD CIFR Section: 882.5950 Biocompatibles UK Ltd. GelSpheres Microspheres…
Biocompatibles UK Limited2004—
*K042231Gelspheres Microspheres and Bead Block Compressible Microspheres
Summary page 1
…G/KRD CIFR Section: 882.5950 Biocompatibles UK Ltd. GelSpheres Microspheres Bead Block Compressible Microspheres 510K Number(s): K042231/K083091 Product Code: HCG/KRD CFR Section: 870.33001882.5950 3 Indications for Use and Intended P…
Biocompatibles UK Limited2004—
*K083091LC Bead Microspheres, Bead Block Compressible Microspheres
Summary page 1
…CIFR Section: 882.5950 Biocompatibles UK Ltd. GelSpheres Microspheres Bead Block Compressible Microspheres 510K Number(s): K042231/K083091 Product Code: HCG/KRD CFR Section: 870.33001882.5950 3 Indications for Use and Intended Populatio…
Biocompatibles UK Limited2008—

Also cleared against K033761: 3 other devices →

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 9 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
  • None of the 5 ancestors has a recall.
  • 3 other devices also cite its predicate K033761.

How does its category compare?

All HCG devices

HCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · HCG

3in 2025

2007: 82008: 92009: 72010: 82011: 92012: 72013: 72014: 52015: 52016: 72017: 52018: 42019: 12020: 22021: 52022: 32023: 22024: 42025: 32026 (partial year): 4
2007high 9 (2008) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HCG

107in 2025

2007: 50 days median2008: 71 days median2009: 48 days median2010: 72 days median2011: 78 days median2012: 30 days median2013: 67 days median2014: 66 days median2015: 60 days median2016: 37 days median2017: 97 days median2018: 173 days median2021: 103 days median2022: 114 days median2024: 49 days median2025: 107 days median2026 (partial year): 30 days median
2007high 173 (2018) · low 30 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HCG

1in 2025

2007: 12008: 32010: 22011: 12013: 22014: 42022: 22024: 12025: 1, 1 Class I2026 (partial year): 1
2007high 4 (2014) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · HCG

537in 2025

2007: 3262008: 7302009: 8212010: 8512011: 8942012: 1,1462013: 1,1032014: 1,7292015: 1,5982016: 1,9912017: 2,4942018: 2,0582019: 1,7632020: 1,7542021: 2,2682022: 6632023: 5682024: 5522025: 537
2007high 2,494 (2017) · low 326 (2007)2025

MAUDE reports naming product code HCG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078501326
20089713730
20097480821
20108722851
20119781894
201273001,146
201376721,103
201456641,729
201556001,598
201673701,991
201759702,494
2018417302,058
20191—01,763
20202—01,754
2021510302,268
202231142663
20232—0568
20244491552
202531071 (1)537
20264301—

What is it indicated for?

LC Bead Microspheres & Bead BlockTM Compressible Microspheres is intended far embolization of hypervascular tumors and arteriovenous malformations.

Indications for use as stated in the FDA summary.

Also cleared against K033761

3 other devices cite the same predicate.

  • K083091LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2008
  • K073417Embozene MicrospheresCelonova Biosciences, Inc. · 2008
  • K042231Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2004

More from Biocompatibles UK Limited

5 FDA decisions under this applicant name. See the company

  • K162373LC Bead LUMIBiocompatibles UK Limited · 2016
  • K083091LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2008
  • K042231Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2004
  • K033761Gelspheres / Beadblock Compressible MicrospheresBiocompatibles UK Limited · 2004

Recent decisions in HCG

The HCG category page

  • K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe (MFR100356)…Cerenovus, Inc. · 2026
  • K261772Target Xtra Detachable CoilStryker Neurovscular · 2026
  • K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2026
  • K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC · 2026
  • K252694Target Detachable CoilStryker Neurovascular · 2025

https://510kreport.com/device/K094018 · printed Nov 4, 2026

Cite this page

510(k) Report. “K094018: LC Bead Microspheres, Bead Block Compressible Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K094018

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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