510(k) · Cleared
ClearedEmbosphere Microspheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosphere Medical · HCG Device, Neurovascular Embolization
Cleared on Apr 26, 2000 as substantially equivalent to K944354 (Interventional Therapeutics Corp., 1994) and 3 other predicates after a 359-day review. Its family tree reaches back 2 generations to 1996. 1 of the 57 devices in its family, counting itself, has a Class I recall. 52 later devices descend from it.
- Decided
- Apr 26, 2000
- Review
- 359 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K961923 (1996). 4 ancestors in all, the oldest K871047 (1987). 52 later devices descend from it, 7 citing it directly. 1 of the 57 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 1 generation backK964112 Berenstein CoilTarget Therapeutics · 1997
- This deviceK991549 Embosphere MicrospheresBiosphere Medical · 2000
- Descendant · cites it directly · 41 of its ownK021397 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 · cites it directly · 11 of its ownK052742 Hepasphere MicrospheresBiosphere Medical, Inc. · 2006
- Descendant · 2 generations on · 10 of its ownK034068 Contour SE MicrospheresBoston Scientific Corp · 2004
- Descendant · 2 generations on · 9 of its ownK181300 Embosphere MicrospheresBiosphere Medical, S.A. · 2018 · Recalled
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K213385 GEM4 generations on · 2022
Most influential descendants
Showing 5 of 52 · See all- K021397Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid EmbolizationBiosphere Medical, Inc. · 2002 · cites it directly41descendants
- K030966Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · cites it directly18descendants
- K052742Hepasphere MicrospheresBiosphere Medical, Inc. · 2006 · cites it directly11descendants
- K034068Contour SE MicrospheresBoston Scientific Corp · 2004 · 2 generations on10descendants
- K181300Embosphere MicrospheresBiosphere Medical, S.A. · 2018 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −1 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| 0 (this device) | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| +1 | 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 |
| +1 | K052742 | Hepasphere Microspheres | Biosphere Medical, Inc. | 2006 | — |
| +2 | K034068 | Contour SE Microspheres | Boston Scientific Corp | 2004 | — |
| +2 | K181300 | Embosphere Microspheres | Biosphere Medical, S.A. | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 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 HCG device
- #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 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 |
|---|---|---|---|
| * | K944354 | Contour EmboliSummary page 1…MBOSPHERE® Microspheres Common/Usual Name: Artificial embolization device Classification Name: Artificial embolization device 3. PREDICATE DEVICES » 1TC Contour Emboli (K944354) + ITC Radiopaque Spherical Emboli (RSE) (K871047) o Target Therapeutics Berenstein Coil (K961923, K964112) 4. DEVICE DESCRIPTION… | 1994 |
| * | K871047 | Radiopaque Spherical Emboli (Rse)Summary page 1…ial embolization device Classification Name: Artificial embolization device 3. PREDICATE DEVICES » 1TC Contour Emboli (K944354) + ITC Radiopaque Spherical Emboli (RSE) (K871047) o Target Therapeutics Berenstein Coil (K961923, K964112) 4. DEVICE DESCRIPTION | EMBOSPHERE® Microspheres ~ are spherical microb… | 1987 |
| * | K961923 | Berenstein CoilSummary page 1…ificial embolization device 3. PREDICATE DEVICES » 1TC Contour Emboli (K944354) + ITC Radiopaque Spherical Emboli (RSE) (K871047) o Target Therapeutics Berenstein Coil (K961923, K964112) 4. DEVICE DESCRIPTION | EMBOSPHERE® Microspheres ~ are spherical microbeads for arterial embolization, made of acrylic… | 1996 |
| * | K964112 | Berenstein CoilSummary page 1…mbolization device 3. PREDICATE DEVICES » 1TC Contour Emboli (K944354) + ITC Radiopaque Spherical Emboli (RSE) (K871047) o Target Therapeutics Berenstein Coil (K961923, K964112) 4. DEVICE DESCRIPTION | EMBOSPHERE® Microspheres ~ are spherical microbeads for arterial embolization, made of acrylic polymer i… | 1997 |
What descends from it? (52)
See all 527 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization | 2002 | 41 |
| K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | 2003 | 18 |
| K052742 | Hepasphere Microspheres | 2006 | 11 |
| K113266 | Gel-Block Embolization Pledgets | 2012 | 8 |
| K150870 | HydroPearl Microspheres, HydroPearl Microspheres | 2015 | 0 |
| K093813 | Occlusin 500 Artificial Embolization Device | 2010 | 0 |
| K050470 | Concentric Embolic Pearls | 2005 | 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 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K021397 (Biosphere Medical, Inc., 2002) has gone furthest, with 41 descendants of its own.
- 6 other devices also cite its predicate K944354.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HCG
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HCG
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HCG
537in 2025
MAUDE reports naming product code HCG, 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 | 8 | 50 | 1 | 326 |
| 2008 | 9 | 71 | 3 | 730 |
| 2009 | 7 | 48 | 0 | 821 |
| 2010 | 8 | 72 | 2 | 851 |
| 2011 | 9 | 78 | 1 | 894 |
| 2012 | 7 | 30 | 0 | 1,146 |
| 2013 | 7 | 67 | 2 | 1,103 |
| 2014 | 5 | 66 | 4 | 1,729 |
| 2015 | 5 | 60 | 0 | 1,598 |
| 2016 | 7 | 37 | 0 | 1,991 |
| 2017 | 5 | 97 | 0 | 2,494 |
| 2018 | 4 | 173 | 0 | 2,058 |
| 2019 | 1 | — | 0 | 1,763 |
| 2020 | 2 | — | 0 | 1,754 |
| 2021 | 5 | 103 | 0 | 2,268 |
| 2022 | 3 | 114 | 2 | 663 |
| 2023 | 2 | — | 0 | 568 |
| 2024 | 4 | 49 | 1 | 552 |
| 2025 | 3 | 107 | 1 (1) | 537 |
| 2026 | 4 | 30 | 1 | — |
What is it indicated for?
EMBOSPHERE ® Microspheres are indicated for embolization of hypervascular tumors
and arteriovenous malformations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991549: Embosphere Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991549
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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