510(k) · Cleared
Recalled · Class II · 2023HydroPearl Microspheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Cleared on Jan 22, 2020 as substantially equivalent to DEN160040 (Biosphere Medical, S.A., 2017) after a 118-day review. Its family tree reaches back 1 generation to 2017. It has been recalled once.
- Decided
- Jan 22, 2020
- Review
- 118 days
- Class
- Class II
- Product code
- NOY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160040 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backDEN160040 Embosphere MicrospheresBiosphere Medical, S.A. · 2017
- This deviceK192684 HydroPearl MicrospheresMicroVention, Inc. · 2020
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) | K192684 | HydroPearl Microspheres | MicroVention, Inc. | 2020 | — |
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
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…[email protected] DATE SUMMARY PREPARED: September 25, 2019 PREDICATE DEVICE: BioSphere Medical S.A. Embosphere Microspheres (DEN160040) REFERENCE DEVICE: HydroPearl™ Microspheres (K150870) DEVICE DESCRIPTION: The HydroPearl™ Microspheres are a pre-fo… | 2017 |
| † | K150870 | HydroPearl Microspheres, HydroPearl Microspheres | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2023 | Class II | Z-0868-2024 | Device Design | Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed. |
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 devicesNOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The HydroPearl® Microspheres are intended for the embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).
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/K192684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192684: HydroPearl Microspheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192684
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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