De Novo · Granted
GrantedEmbosphere Microspheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosphere Medical, S.A. · NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Granted on Jun 21, 2017 as a new device type through De Novo after a 320-day review. 4 later devices descend from it.
- Decided
- Jun 21, 2017
- Review
- 320 days
- Class
- Class II
- Product code
- NOY
- Recalls
- None
4 later devices descend from it, 3 citing it directly.
- This deviceDEN160040 Embosphere MicrospheresBiosphere Medical, S.A. · 2017
- Descendant · cites it directly · 1 of its ownK180102 Embozene Color-Advanced MicrospheresBoston Scientific · 2018
- Descendant · 2 generations on · 0 of its ownK242608 Embozene Color-Advanced MicrospheresVarian Medical Systems, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK203276 Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead…Biocompatibles UK Ltd (Part of Boston Scientific Corporation · 2021
- Descendant · cites it directly · 0 of its ownK192684 HydroPearl MicrospheresMicroVention, Inc. · 2020 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K180102Embozene Color-Advanced MicrospheresBoston Scientific · 2018 · cites it directly1descendant
- K242608Embozene Color-Advanced MicrospheresVarian Medical Systems, Inc. · 2025 · 2 generations on0descendants
- K203276Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm…Biocompatibles UK Ltd (Part of Boston Scientific Corporation · 2021 · cites it directly0descendants
- K192684HydroPearl MicrospheresMicroVention, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN160040 | Embosphere Microspheres | Biosphere Medical, S.A. | 2017 | — |
| +1 | K180102 | Embozene Color-Advanced Microspheres | Boston Scientific | 2018 | — |
| +2 | K242608 | Embozene Color-Advanced Microspheres | Varian Medical Systems, Inc. | 2025 | — |
| +1 | K203276 | Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500… | Biocompatibles UK Ltd (Part of Boston Scientific Corporation | 2021 | — |
| +1 | K192684 | HydroPearl Microspheres | MicroVention, Inc. | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo 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 NOY? 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 NOY device
- #1 K203276 Bead Block (100 - 300µm, 1ml), Bead Block (300…score 1.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K180102 (Boston Scientific, 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NOY devicesNOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NOY
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NOY
Too few NOY 510(k)s in any year since 2007 to give a median.
Recalls per year · NOY
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NOY
3in 2019
MAUDE reports naming product code NOY, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular tumors, including symptomatic uterine fibroids, and prostatic arteries for symptomatic benign prostatic hyperplasia (BPH).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN160040 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN160040: Embosphere Microspheres.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN160040
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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