510(k) · Cleared
ClearedEmbozene Color-Advanced Microspheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Cleared on Apr 19, 2018 as substantially equivalent to DEN160040 (Biosphere Medical, S.A., 2017) after a 93-day review. Its family tree reaches back 1 generation to 2017. 1 later device descends from it.
- Decided
- Apr 19, 2018
- Review
- 93 days
- Class
- Class II
- Product code
- NOY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160040 (2017). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K242608Embozene Color-Advanced MicrospheresVarian Medical Systems, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160040 | Embosphere Microspheres | Biosphere Medical, S.A. | 2017 | — |
| 0 (this device) | K180102 | Embozene Color-Advanced Microspheres | Boston Scientific | 2018 | — |
| +1 | K242608 | Embozene Color-Advanced Microspheres | Varian Medical Systems, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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
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 |
|---|---|---|---|
| * | DEN160040 | Embosphere MicrospheresSummary page 4…Microspheres (Embosphere PROTM Prostatic Artery Embolization Kit), Merit Medical Systems Inc. DEN160040 (21-Jun-2017) Reference Device EmbozeneTM Color-Advanced Microspheres, Boston Scientific Corpor… | 2017 |
| † | K141209 | Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242608 | Embozene Color-Advanced Microspheres | 2025 | 0 |
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?
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. 2018, 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?
Embozene Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).
This device is not intended for neurovascular use.
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/K180102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180102: Embozene Color-Advanced Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180102
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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