510(k) · Cleared
ClearedEmbozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres, Oncozene 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 Aug 7, 2014 as substantially equivalent to K073417 (Celonova Biosciences, Inc., 2008) and 3 other predicates after a 90-day review. Its family tree reaches back 9 generations to 1996. 1 later device descends from it.
- Decided
- Aug 7, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K961923 (1996). 19 ancestors in all, the oldest K871047 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 5 generations between
- 3 generations backK073417 Embozene MicrospheresCelonova Biosciences, Inc. · 2008
- 2 generations backK132675 Embozene MicrospheresCelonova Biosciences, Inc. · 2013
- 1 generation backK133447 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
- This deviceK141209 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK242794 ONCOZENE MicrospheresVarian Medical Systems, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 8 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 7 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 6 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 5 generations backK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
- 4 generations backK034068 Contour SE MicrospheresBoston Scientific Corp · 2004
- 3 generations backK073417 Embozene MicrospheresCelonova Biosciences, Inc. · 2008
- 2 generations backK132675 Embozene MicrospheresCelonova Biosciences, Inc. · 2013
- 1 generation backK133447 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
- This deviceK141209 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K242794ONCOZENE MicrospheresVarian Medical Systems, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −8 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −7 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −6 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −5 | K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | Boston Scientific Corp | 2003 | 1 |
| −4 | K034068 | Contour SE Microspheres | Boston Scientific Corp | 2004 | — |
| −3 | K073417 | Embozene Microspheres | Celonova Biosciences, Inc. | 2008 | — |
| −2 | K132675 | Embozene Microspheres | Celonova Biosciences, Inc. | 2013 | — |
| −1 | K133447 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres | Celonova Biosciences, Inc. | 2014 | — |
| 0 (this device) | K141209 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)… | Celonova Biosciences, Inc. | 2014 | — |
| +1 | 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 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K073417 | Embozene MicrospheresSummary page 5…rs and Product Codes of Predicate Devices Trade Name: Embozene® Microspheres Manufacturer: CeloNova BioSciences, Inc. 510(k) Number: K073417/ K132675/K133447 Product Code: KRD, NAJ, 21 CFR 870.3300 Trade Name: ONCOZENE™ Microspheres Manufact… | 2008 |
| * | K132675 | Embozene MicrospheresSummary page 5…oduct Codes of Predicate Devices Trade Name: Embozene® Microspheres Manufacturer: CeloNova BioSciences, Inc. 510(k) Number: K073417/ K132675/K133447 Product Code: KRD, NAJ, 21 CFR 870.3300 Trade Name: ONCOZENE™ Microspheres Manufacturer:… | 2013 |
| * | K133447 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) MicrospheresSummary page 5…des of Predicate Devices Trade Name: Embozene® Microspheres Manufacturer: CeloNova BioSciences, Inc. 510(k) Number: K073417/ K132675/K133447 Product Code: KRD, NAJ, 21 CFR 870.3300 Trade Name: ONCOZENE™ Microspheres Manufacturer:… | 2014 |
| * | K130307 | Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres…Summary page 5…e: KRD, NAJ, 21 CFR 870.3300 Trade Name: ONCOZENE™ Microspheres Manufacturer: CeloNova BioSciences, Inc. 510(k) Number: K130307 Product Code: KRD, 21 CFR 870.3300 B/ 1 3. Indicati… | 2013 |
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 |
|---|---|---|---|
| K242794 | ONCOZENE Microspheres | 2024 | 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 18 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K242794 (Varian Medical Systems, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K073417.
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. 2014, 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?
Embozene® Microspheres are indicated for the embolization of arteriovenous malformations and hypervascular tumors including uterine fibroids and hepatoma.
ONCOZENE™ Microspheres are indicated for the embolization of arteriovenous malformations and hypervascular tumors including hepatoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141209: Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres, Oncozene Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141209
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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