510(k) · Cleared
ClearedEmbozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Celonova Biosciences, Inc. · NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
Cleared on Feb 24, 2014 as substantially equivalent to K073417 (Celonova Biosciences, Inc., 2008) and 3 other predicates after a 104-day review. Its family tree reaches back 8 generations to 1996. 2 later devices descend from it.
- Decided
- Feb 24, 2014
- Review
- 104 days
- Class
- Class II
- Product code
- NAJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K961923 (1996). 17 ancestors in all, the oldest K871047 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 7 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 6 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 5 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 4 generations backK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
- 3 generations backK034068 Contour SE MicrospheresBoston Scientific Corp · 2004
- 2 generations backK073417 Embozene MicrospheresCelonova Biosciences, Inc. · 2008
- 1 generation backK132675 Embozene MicrospheresCelonova Biosciences, Inc. · 2013
- This deviceK133447 Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored)…Celonova Biosciences, Inc. · 2014
- 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 |
|---|---|---|---|---|---|
| −8 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −7 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −6 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −5 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −4 | K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | Boston Scientific Corp | 2003 | 1 |
| −3 | K034068 | Contour SE Microspheres | Boston Scientific Corp | 2004 | — |
| −2 | K073417 | Embozene Microspheres | Celonova Biosciences, Inc. | 2008 | — |
| −1 | K132675 | Embozene Microspheres | Celonova Biosciences, Inc. | 2013 | — |
| 0 (this device) | 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 | — |
| +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 NAJ? 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 NAJ device
- #1 K233813 Bearing nsPVA Express™score 8.3 · 7 generations · no Class I recall
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 1…es of Predicate Devices Trade Name: Embozene® Microspheres Manufacturer: CeloNova BioSciences, Inc. 5 10(k) Number: K07341 7/ K 132675 Product Code: KRD, 21 CFR 870.3300 Trade Name: Embosphere® Microspheres Manufa… | 2008 |
| * | K132675 | Embozene MicrospheresSummary page 1…icate Devices Trade Name: Embozene® Microspheres Manufacturer: CeloNova BioSciences, Inc. 5 10(k) Number: K07341 7/ K 132675 Product Code: KRD, 21 CFR 870.3300 Trade Name: Embosphere® Microspheres Manufacturer:… | 2013 |
| * | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationSummary page 1…ospheres Manufacturer: BioSphere Medical, Inc. (Acquired by Merit Medical Systems, Inc.) 5 10O(k) Number: K02 1397 Product Code: NAJ, 21 CER 870.3300 Trade Name: Contour®D PVA Embolization Particles Manu… | 2002 |
| * | K030966 | Contour Emboli Pva and Fastracker-325 Infusion CatheterSummary page 2…KI 33447 Page 2 of 6 510(k) Number: K030966 Product Code: NAJ, 21 CFR 870.3300 3. Indications for Use and Intended Purpose Embozene® Microspheres are int… | 2003 |
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 18 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 17 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 NAJ devicesNAJ Agents, Embolic, For Treatment Of Uterine Fibroids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NAJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NAJ
Too few NAJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NAJ
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAJ
3in 2025
MAUDE reports naming product code NAJ, 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 | 0 | — | 0 | 46 |
| 2008 | 1 | — | 0 | 23 |
| 2009 | 0 | — | 1 | 11 |
| 2010 | 1 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 21 |
| 2013 | 1 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Ernbozene®I Microspheres are indicated for the embolization of arteriovenous mnalformations and hypervascular tumors, including uterine fibroids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133447: Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133447
Report an extraction error
Are you the manufacturer?
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