510(k) · Cleared
ClearedQuadrasphere 30 to 60
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosphere Medical, Inc. · HCG Device, Neurovascular Embolization
Cleared on Mar 8, 2012 as substantially equivalent to K052742 (Biosphere Medical, Inc., 2006) after a 72-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.
- Decided
- Mar 8, 2012
- Review
- 72 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010026 (2001). 12 ancestors in all, the oldest K871047 (1987). 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 backK052742 Hepasphere MicrospheresBiosphere Medical, Inc. · 2006
- This deviceK113822 Quadrasphere 30 to 60Biosphere Medical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK151187 QuadraSphere MicrospheresBiosphere Medical, S.A. · 2015
Most influential descendants
Showing 1 of 1 · See all- K151187QuadraSphere MicrospheresBiosphere Medical, S.A. · 2015 · 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 | K052742 | Hepasphere Microspheres | Biosphere Medical, Inc. | 2006 | — |
| 0 (this device) | K113822 | Quadrasphere 30 to 60 | Biosphere Medical, Inc. | 2012 | — |
| +1 | K151187 | QuadraSphere Microspheres | Biosphere Medical, S.A. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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? (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 |
|---|---|---|---|
| * | K052742 | Hepasphere MicrospheresSummary page 1…QuadraSphere Microspheres Classification Name: Neurovascular embolization device Predicate Device Premarket Notification: K052742 Manufacturer: BioSphere Medical, S.A. Class 11 Classification… | 2006 |
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 |
|---|---|---|---|
| K151187 | QuadraSphere Microspheres | 2015 | 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 11 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K151187 (Biosphere Medical, S.A., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K052742.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
QuadraSphere Microspheres are indicated for embolization of hypervascularized tumors and peripheral arteriovenous malformations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113822: Quadrasphere 30 to 60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113822
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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