510(k) · Cleared
ClearedEmbozene Microspheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Celonova Biosciences, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Dec 15, 2008 as substantially equivalent to K033761 (Biocompatibles UK Limited, 2004) and 3 other predicates after a 377-day review. Its family tree reaches back 6 generations to 1996. 6 later devices descend from it.
- Decided
- Dec 15, 2008
- Review
- 377 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K961923 (1996). 15 ancestors in all, the oldest K871047 (1987). 6 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 5 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 4 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 3 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 2 generations backK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
- 1 generation backK034068 Contour SE MicrospheresBoston Scientific Corp · 2004
- This deviceK073417 Embozene MicrospheresCelonova Biosciences, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK132675 Embozene MicrospheresCelonova Biosciences, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK133447 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK130307 Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML…Celonova Biosciences, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK141209 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK242794 ONCOZENE MicrospheresVarian Medical Systems, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K132675Embozene MicrospheresCelonova Biosciences, Inc. · 2013 · cites it directly4descendants
- K133447Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) MicrospheresCelonova Biosciences, Inc. · 2014 · cites it directly2descendants
- K130307Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres…Celonova Biosciences, Inc. · 2013 · cites it directly2descendants
- K141209Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres…Celonova Biosciences, Inc. · 2014 · cites it directly1descendant
- K242794ONCOZENE MicrospheresVarian Medical Systems, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −5 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −4 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −3 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −2 | K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | Boston Scientific Corp | 2003 | 1 |
| −1 | K034068 | Contour SE Microspheres | Boston Scientific Corp | 2004 | — |
| 0 (this device) | K073417 | Embozene Microspheres | Celonova Biosciences, Inc. | 2008 | — |
| +1 | K132675 | Embozene Microspheres | Celonova Biosciences, Inc. | 2013 | — |
| +1 | K133447 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres | Celonova Biosciences, Inc. | 2014 | — |
| +1 | K130307 | Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene… | Celonova Biosciences, Inc. | 2013 | — |
| +1 | K141209 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)… | Celonova Biosciences, Inc. | 2014 | — |
| +2 | K242794 | ONCOZENE Microspheres | Varian Medical Systems, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2024 | 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? (4)
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 |
|---|---|---|---|
| * | K033761 | Gelspheres / Beadblock Compressible MicrospheresSummary page 1…redicate Devices: Embozenew Microspheres are substantially equivalent to these predicate devices: Biocompatibles Gelspheres'Microspheres (Via[) (colored) - K033761 Biocompatibtes Bead Blockw Microspheres (Syringe) (colored) - K033761 Boston Scientific Contour SE" Mic… | 2004 |
| * | K032707 | Contour SE Microspheres (Syringe)Summary page 1…res (Via[) (colored) - K033761 Biocompatibtes Bead Blockw Microspheres (Syringe) (colored) - K033761 Boston Scientific Contour SE" Microspheres K032707 Boston Scientific Contour SE" Microspheres K034068 Boston Scientific Contour SE' Microspheres K071634… | 2003 |
| * | K034068 | Contour SE MicrospheresSummary page 1…Blockw Microspheres (Syringe) (colored) - K033761 Boston Scientific Contour SE" Microspheres K032707 Boston Scientific Contour SE" Microspheres K034068 Boston Scientific Contour SE' Microspheres K071634 Clinical Data. None required. Adverse Safety & Effecti… | 2004 |
| * | K071634 | Modification to:Contour SE MicrospheresSummary page 1…oston Scientific Contour SE" Microspheres K032707 Boston Scientific Contour SE" Microspheres K034068 Boston Scientific Contour SE' Microspheres K071634 Clinical Data. None required. Adverse Safety & Effectiveness Information: None. Signature _ _ - '… | 2007 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132675 | Embozene Microspheres | 2013 | 4 |
| K133447 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres | 2014 | 2 |
| K130307 | Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres… | 2013 | 2 |
| K141209 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres… | 2014 | 1 |
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 12 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K132675 (Celonova Biosciences, Inc., 2013) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K033761.
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?
EmbozeneTM Microspheres are indicated for the embolization of
hypervascular tumors and arteriovenous malformations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073417 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073417: Embozene Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073417
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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