510(k) · Cleared

Cleared

Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)

K203276510(k) TraditionalCleared Apr 20, 2021165-day reviewClass II21 CFR 876.5550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biocompatibles UK Ltd (Part of Boston Scientific Corporation · NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

Cleared on Apr 20, 2021 as substantially equivalent to DEN160040 (Biosphere Medical, S.A., 2017) after a 165-day review. Its family tree reaches back 1 generation to 2017.

Decided: Apr 20, 2021
Review: 165 days
Class: Class II
Product code: NOY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN160040 (2017). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backDEN160040 Embosphere MicrospheresBiosphere Medical, S.A. · 2017
This deviceK203276 Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead…Biocompatibles UK Ltd (Part of Boston Scientific Corporation · 2021

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)	K203276	Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500…	Biocompatibles UK Ltd (Part of Boston Scientific Corporation	2021	—

FIG. 1 — Lineage of K203276, 2017–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K192684 HydroPearl Microspheresscore -3.3 · 1 generation · no Class I recall

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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	Applicant	Decided	Recalls
*	DEN160040	Embosphere Microspheres Summary page 5 …21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code DEN160040 Embosphere Microspheres NOY K150876…	Biosphere Medical, S.A.	2017	—
†	K150876	Bead Block	Biocompatibles UK, Ltd.	2016	—

Also cleared against DEN160040: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
2 other devices also cite its predicate DEN160040.

How does its category compare?

All NOY devices

NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · NOY

1in 2021

2007high 1 (2017) · low 0 (2007)2026

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

2007high 1 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NOY

3in 2019

2007high 3 (2019) · low 0 (2007)2025

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?

Bead Block microspheres are intended to be used for the embolization of hypervascular tumours, including uterine fibroids (UFE) and arteriovenous malformations (AVMs). Bead Block microspheres are also intended for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K203276 · printed Nov 6, 2026

Cite this page

510(k) Report. “K203276: Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203276

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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