510(k) Report

510(k) · Cleared

Cleared

Hepasphere Microspheres

K052742510(k) TraditionalCleared Nov 7, 2006403-day reviewClass II21 CFR 870.3300

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

Biosphere Medical, Inc. · KRD Device, Vascular, For Promoting Embolization

Cleared on Nov 7, 2006 as substantially equivalent to K042231 (Biocompatibles UK Limited, 2004) and 4 other predicates after a 403-day review. Its family tree reaches back 4 generations to 2001. 11 later devices descend from it.

Decided
Nov 7, 2006
Review
403 days
Class
Class II
Product code
KRD
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K010026 (2001). 11 ancestors in all, the oldest K871047 (1987). 11 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor1994: 1 other ancestor1997: 1 other ancestor1996: 1 other ancestor1987: 1 other ancestor2012: 2 descendants cleared2015: 1 descendant cleared2014: 2 descendants cleared2018: 3 descendants cleared2017: 1 descendant cleared2019: 2 descendants clearedK010026 · 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 · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant K042231 · 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. · 20010
  1. Root · 4 generations backK010026 Embogold MicrosphereBiosphere Medical, Inc. · 2001
  2. 3 generations backK023089 Gelspheres Embolic AgentBiocure, Inc. · 2002
  3. 2 generations backK033761 Gelspheres / Beadblock Compressible MicrospheresBiocompatibles UK Limited · 2004
  4. 1 generation backK042231 Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2004
  5. This deviceK052742 Hepasphere MicrospheresBiosphere Medical, Inc. · 2006
  6. Descendant · cites it directly · 8 of its ownK113266 Gel-Block Embolization PledgetsVascular Solutions, Inc. · 2012
  7. Descendant · 2 generations on · 2 of its ownK143038 Gel-Block 10X embolization pledgetsVascular Solutions, Inc. · 2014
  8. Descendant · 2 generations on · 2 of its ownK133237 Gel-Bead Embolization SpheresVascular Solutions, Inc. · 2014
  9. Descendant · 3 generations on · 1 of its ownK181021 EmboCube Embolization GelatinBiosphere Medical, S.A. · 2018
  10. Descendant · 2 generations on · 1 of its ownK181051 IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE…Shape Memory Medical · 2018

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2012: 22014: 22015: 12017: 12018: 32019: 2
2012high 3 (2018) · low 0 (2013)2026

Most influential descendants

Showing 5 of 11 · See all
  • K113266Gel-Block Embolization PledgetsVascular Solutions, Inc. · 2012 · cites it directly8descendants
  • K143038Gel-Block 10X embolization pledgetsVascular Solutions, Inc. · 2014 · 2 generations on2descendants
  • K133237Gel-Bead Embolization SpheresVascular Solutions, Inc. · 2014 · 2 generations on2descendants
  • K181021EmboCube Embolization GelatinBiosphere Medical, S.A. · 2018 · 3 generations on1descendant
  • K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical · 2018 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K010026Embogold MicrosphereBiosphere Medical, Inc.2001—
−3K023089Gelspheres Embolic AgentBiocure, Inc.2002—
−2K033761Gelspheres / Beadblock Compressible MicrospheresBiocompatibles UK Limited2004—
−1K042231Gelspheres Microspheres and Bead Block Compressible MicrospheresBiocompatibles UK Limited2004—
0 (this device)K052742Hepasphere MicrospheresBiosphere Medical, Inc.2006—
+1K113266Gel-Block Embolization PledgetsVascular Solutions, Inc.2012—
+2K143038Gel-Block 10X embolization pledgetsVascular Solutions, Inc.2014—
+2K133237Gel-Bead Embolization SpheresVascular Solutions, Inc.2014—
+3K181021EmboCube Embolization GelatinBiosphere Medical, S.A.2018—
+2K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE…Shape Memory Medical2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199410
199610
199710
200010
200210
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201420
201510
201710
201830
201920
FIG. 1 — Lineage of K052742, 2001–2019Source: 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 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. #1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 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? (5)

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
*K042231Gelspheres Microspheres and Bead Block Compressible Microspheres
Summary page 1
…e: Vascular embolization device 3. PREDICATE DEVICES *Biocompatibles UK Ltd., GeiSpheres, BeadBlock Compressible Microspheres (K042231I) *Boston Scientific Corporation, Contour SE (K022427, K032542) *Interventional Therapeutics Corp…
Biocompatibles UK Limited2004—
*K022427Contour SE Microspheres
Summary page 1
…*Biocompatibles UK Ltd., GeiSpheres, BeadBlock Compressible Microspheres (K042231I) *Boston Scientific Corporation, Contour SE (K022427, K032542) *Interventional Therapeutics Corporation, Contour Emboli (K9443 54) *BioSphere Medical,…
Boston Scientific Corp2002—
*K032542Modification to Contour SE Microspheres
Summary page 1
…Biocompatibles UK Ltd., GeiSpheres, BeadBlock Compressible Microspheres (K042231I) *Boston Scientific Corporation, Contour SE (K022427, K032542) *Interventional Therapeutics Corporation, Contour Emboli (K9443 54) *BioSphere Medical, Inc., Em…
Boston Scientific Corp2003—
*K944354Contour Emboli
Summary page 1
…pheres (K042231I) *Boston Scientific Corporation, Contour SE (K022427, K032542) *Interventional Therapeutics Corporation, Contour Emboli (K9443 54) *BioSphere Medical, Inc., Embospheres (K991549) 4. DEVICE DESCRIPTION BioSphere Medical, Inc.…
Interventional Therapeutics Corp.1994—
*K991549Embosphere Microspheres
Summary page 1
…Contour SE (K022427, K032542) *Interventional Therapeutics Corporation, Contour Emboli (K9443 54) *BioSphere Medical, Inc., Embospheres (K991549) 4. DEVICE DESCRIPTION BioSphere Medical, Inc., QuadraSphereTM Microspheres are sterile, biocompatib…
Biosphere Medical2000—

Also cleared against K042231: 2 other devices →

What descends from it? (11)

See all 11

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K113266Gel-Block Embolization PledgetsVascular Solutions, Inc.20128
K113822Quadrasphere 30 to 60Biosphere Medical, Inc.20121
K151187QuadraSphere MicrospheresBiosphere Medical, S.A.20150

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 5 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
  • None of the 11 ancestors has a recall.
  • Of its descendants, K113266 (Vascular Solutions, Inc., 2012) has gone furthest, with 8 descendants of its own.
  • 2 other devices also cite its predicate K042231.

How does its category compare?

All KRD devices

KRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRD

9in 2025

2007: 22008: 52009: 42010: 32011: 52012: 82013: 112014: 72015: 112016: 42017: 42018: 42019: 62020: 42021: 32022: 82023: 22024: 62025: 92026 (partial year): 7
2007high 11 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRD

60in 2025

2008: 84 days median2009: 27 days median2010: 150 days median2011: 36 days median2012: 30 days median2013: 33 days median2014: 134 days median2015: 130 days median2016: 164 days median2017: 89 days median2018: 62 days median2019: 178 days median2020: 137 days median2021: 134 days median2022: 175 days median2024: 70 days median2025: 60 days median2026 (partial year): 70 days median
2007high 178 (2019) · low 27 (2009)2026

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

Recalls per year · KRD

1in 2024

2010: 12013: 12023: 12024: 12026 (partial year): 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KRD

1,572in 2025

2007: 212008: 142009: 402010: 612011: 1022012: 1372013: 2442014: 1592015: 3372016: 4372017: 7362018: 1,0662019: 1,1852020: 1,1672021: 1,4442022: 1,4982023: 1,3712024: 1,5352025: 1,572
2007high 1,572 (2025) · low 14 (2008)2025

MAUDE reports naming product code KRD, 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
20072—021
2008584014
2009427040
20103150161
20115360102
20128300137
201311331244
201471340159
2015111300337
201641640437
20174890736
201846201,066
2019617801,185
2020413701,167
2021313401,444
2022817501,498
20232—11,371
202467011,535
202596001,572
20267701—

What is it indicated for?

QuadraSphere Microspheres are indicated for embolization of hypervascularized tumors and peripheral arteriovenous malformations.

Indications for use as stated in the FDA summary.

Also cleared against K042231

2 other devices cite the same predicate.

  • K094018LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2010
  • K083091LC Bead Microspheres, Bead Block Compressible MicrospheresBiocompatibles UK Limited · 2008

More from Biosphere Medical, Inc.

6 FDA decisions under this applicant name. See the company

  • K113822Quadrasphere 30 to 60Biosphere Medical, Inc. · 2012
  • K062126Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135Biosphere Medical, Inc. · 2006
  • K061171Sequitor Steerable Guidewire, Models SQR18XX and SQR14XXBiosphere Medical, Inc. · 2006
  • K021397Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationBiosphere Medical, Inc. · 2002
  • K010026Embogold MicrosphereBiosphere Medical, Inc. · 2001

Recent decisions in KRD

The KRD category page

  • K262798LOBO Vascular Occlusion SystemOkami Medical, Inc. · 2026
  • K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd. · 2026
  • K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation · 2026
  • K261866Concerto Versa™ Detachable CoilMedtronic, Inc. · 2026
  • K260635HARBOR Occlusion DeviceNuvascular, Inc. · 2026

https://510kreport.com/device/K052742 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052742: Hepasphere Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052742

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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