510(k) · Cleared
ClearedONCOZENE Microspheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Oct 16, 2024 as substantially equivalent to K141209 (Celonova Biosciences, Inc., 2014) after a 30-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Oct 16, 2024
- Review
- 30 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K961923 (1996). 20 ancestors in all, the oldest K871047 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 6 generations between
- 3 generations backK132675 Embozene MicrospheresCelonova Biosciences, Inc. · 2013
- 2 generations backK133447 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
- 1 generation backK141209 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
- This deviceK242794 ONCOZENE MicrospheresVarian Medical Systems, Inc. · 2024
Show all 10 generations
- Root · 10 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 9 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 8 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 7 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 6 generations backK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
- 5 generations backK034068 Contour SE MicrospheresBoston Scientific Corp · 2004
- 4 generations backK073417 Embozene MicrospheresCelonova Biosciences, Inc. · 2008
- 3 generations backK132675 Embozene MicrospheresCelonova Biosciences, Inc. · 2013
- 2 generations backK133447 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
- 1 generation backK141209 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
- This deviceK242794 ONCOZENE MicrospheresVarian Medical Systems, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −9 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −8 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −7 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −6 | K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | Boston Scientific Corp | 2003 | 1 |
| −5 | K034068 | Contour SE Microspheres | Boston Scientific Corp | 2004 | — |
| −4 | K073417 | Embozene Microspheres | Celonova Biosciences, Inc. | 2008 | — |
| −3 | K132675 | Embozene Microspheres | Celonova Biosciences, Inc. | 2013 | — |
| −2 | K133447 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres | Celonova Biosciences, Inc. | 2014 | — |
| −1 | K141209 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)… | Celonova Biosciences, Inc. | 2014 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K141209 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres…Summary page 5…Cardiovascular Regulation Number: 21 CFR Part 870.3300 Product Codes: KRD III. Predicate Device: ONCOZENE Microspheres (K141209) IV. Subject Device Description: ONCOZENE Microspheres (hereafter may be referenced as ONCOZENE Microspheres or… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 20 ancestors has a recall of any class.
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. 2024, 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 intended for embolization of arteriovenous malformations and hypervascular tumors including hepatoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242794: 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/K242794
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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