510(k) · Cleared
ClearedEmbosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosphere Medical, Inc. · NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
Cleared on Nov 22, 2002 as substantially equivalent to K991549 (Biosphere Medical, 2000) and 1 other predicate after a 204-day review. Its family tree reaches back 3 generations to 1996. 1 of the 48 devices in its family, counting itself, has a Class I recall. 41 later devices descend from it.
- Decided
- Nov 22, 2002
- Review
- 204 days
- Class
- Class II
- Product code
- NAJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961923 (1996). 6 ancestors in all, the oldest K871047 (1987). 41 later devices descend from it, 10 citing it directly. 1 of the 48 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 2 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 1 generation backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- This deviceK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- Descendant · cites it directly · 18 of its ownK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
- Descendant · 2 generations on · 10 of its ownK034068 Contour SE MicrospheresBoston Scientific Corp · 2004
- Descendant · cites it directly · 9 of its ownK181300 Embosphere MicrospheresBiosphere Medical, S.A. · 2018 · Recalled
- Descendant · 2 generations on · 7 of its ownK183120 EmboCube Embolization GelatinBiosphere Medical, S.A. · 2019
- Descendant · 3 generations on · 6 of its ownK073417 Embozene MicrospheresCelonova Biosciences, Inc. · 2008
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K213385 GEM3 generations on · 2022
Most influential descendants
Showing 5 of 41 · See all- K030966Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · cites it directly18descendants
- K034068Contour SE MicrospheresBoston Scientific Corp · 2004 · 2 generations on10descendants
- K181300Embosphere MicrospheresBiosphere Medical, S.A. · 2018 · cites it directly9descendants
- K183120EmboCube Embolization GelatinBiosphere Medical, S.A. · 2019 · 2 generations on7descendants
- K073417Embozene MicrospheresCelonova Biosciences, Inc. · 2008 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −2 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −1 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| 0 (this device) | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| +1 | K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | Boston Scientific Corp | 2003 | 1 |
| +2 | K034068 | Contour SE Microspheres | Boston Scientific Corp | 2004 | — |
| +1 | K181300 | Embosphere Microspheres | Biosphere Medical, S.A. | 2018 | 1 |
| +2 | K183120 | EmboCube Embolization Gelatin | Biosphere Medical, S.A. | 2019 | — |
| +3 | K073417 | Embozene Microspheres | Celonova Biosciences, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 1 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K991549 | Embosphere MicrospheresSummary page 1…zation Device (2 1 CFR 882.5950 and 21 CFR 870.3300) 3. PREDICATE DEVICES Embosphere@ Microspheres as reviewed under K99 1549 and EmboGoldTM Microspheres as reviewed under KO 10026. 4. INTENDED USE Embosphere@and EmboGoldTMMicrospheres are… | 2000 |
| * | K010026 | Embogold Microsphere | 2001 |
What descends from it? (41)
See all 4110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | 2003 | 18 |
| K181300 | Embosphere Microspheres | 2018 | 9 |
| K150876 | Bead Block | 2016 | 4 |
| K133237 | Gel-Bead Embolization Spheres | 2014 | 2 |
| K133447 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres | 2014 | 2 |
| K220567 | Easi-Vue embolic microspheres System | 2022 | 1 |
| K061790 | Pva Plus, Maxistat Pva, Microstat Pva Foam Embolization Particles | 2006 | 1 |
| K150870 | HydroPearl Microspheres, HydroPearl Microspheres | 2015 | 0 |
| K093813 | Occlusin 500 Artificial Embolization Device | 2010 | 0 |
| K081768 | Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles | 2008 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K213385GEMObsidio, Inc. · 2022 · 3 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K030966 (Boston Scientific Corp, 2003) has gone furthest, with 18 descendants of its own.
- 6 other devices also cite its predicate K991549.
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.
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?
Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021397 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021397
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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