510(k) · Cleared
ClearedOncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres 100UM, 2ML, Oncozene Microsphere
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 Mar 4, 2013 as substantially equivalent to K073417 (Celonova Biosciences, Inc., 2008) after a 25-day review. Its family tree reaches back 7 generations to 1996. 2 later devices descend from it.
- Decided
- Mar 4, 2013
- Review
- 25 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K961923 (1996). 16 ancestors in all, the oldest K871047 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 6 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 5 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 4 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 3 generations backK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
- 2 generations backK034068 Contour SE MicrospheresBoston Scientific Corp · 2004
- 1 generation backK073417 Embozene MicrospheresCelonova Biosciences, Inc. · 2008
- This deviceK130307 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −6 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −5 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −4 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −3 | K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | Boston Scientific Corp | 2003 | 1 |
| −2 | K034068 | Contour SE Microspheres | Boston Scientific Corp | 2004 | — |
| −1 | K073417 | Embozene Microspheres | Celonova Biosciences, Inc. | 2008 | — |
| 0 (this device) | 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 |
|---|---|---|
| 2014 | 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? (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 |
|---|---|---|---|
| * | K073417 | Embozene MicrospheresSummary page 1…code of predicate device Trade Name: Embozene Microspheres Manufacturer: CeloNova BioSciences, Inc. 510(k) number: K073417 Product code : KRD, 21 CFR 870.3300 3. Indications for Use and Intended Purpose ONCOZENE m Microspheres are int… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 17 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K141209 (Celonova Biosciences, Inc., 2014) has gone furthest, with 1 descendant 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. 2013, 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?
ONCOZENE™ 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/K130307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130307: Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres 100UM, 2ML, Oncozene Microsphere.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130307
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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