510(k) · Cleared
ClearedBearing Nspva Embolization Particles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
Cleared on Jun 7, 2013 as substantially equivalent to K100663 (Boston Scientific Corporation, 2010) after a 126-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Jun 7, 2013
- Review
- 126 days
- Class
- Class II
- Product code
- NAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K961923 (1996). 9 ancestors in all, the oldest K871047 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK961923 Berenstein CoilTarget Therapeutics · 1996
- 5 generations backK964112 Berenstein CoilTarget Therapeutics · 1997
- 4 generations backK991549 Embosphere MicrospheresBiosphere Medical · 2000
- 3 generations backK021397 Embosphere Microspheres and Embogold Microspheres for Use in Uterine…Biosphere Medical, Inc. · 2002
- 2 generations backK030966 Contour Emboli Pva and Fastracker-325 Infusion CatheterBoston Scientific Corp · 2003 · Recalled
- 1 generation backK100663 Contour Embolization Particles, Models M0017600121, M0017600221…Boston Scientific Corporation · 2010
- This deviceK130259 Bearing Nspva Embolization ParticlesMerit Medical Systems, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK233813 Bearing nsPVA Express™Merit Medical Systems, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K233813Bearing nsPVA Express™Merit Medical Systems, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961923 | Berenstein Coil | Target Therapeutics | 1996 | — |
| −5 | K964112 | Berenstein Coil | Target Therapeutics | 1997 | — |
| −4 | K991549 | Embosphere Microspheres | Biosphere Medical | 2000 | — |
| −3 | K021397 | Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid… | Biosphere Medical, Inc. | 2002 | — |
| −2 | K030966 | Contour Emboli Pva and Fastracker-325 Infusion Catheter | Boston Scientific Corp | 2003 | 1 |
| −1 | K100663 | Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321 | Boston Scientific Corporation | 2010 | — |
| 0 (this device) | K130259 | Bearing Nspva Embolization Particles | Merit Medical Systems, Inc. | 2013 | — |
| +1 | K233813 | Bearing nsPVA Express™ | Merit Medical Systems, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 NAJ? 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 NAJ device
- #1 K233813 Bearing nsPVA Express™score 8.3 · 7 generations · 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 |
|---|---|---|---|
| * | K100663 | Contour Embolization Particles, Models M0017600121, M0017600221, M0017600321Summary page 1…Vascular Embolization Device Predicate Device Trade Name: Classification Name: Premarket Notification: Contour™ Embolization Particles Vascular Embolization Device K100663 Manufacturer: Boston Scientific Corporation Class: Il : 21 CFR: 870.3300 Classification FDA Product Code: KRD and NAJ Review Pan… | 2010 |
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 |
|---|---|---|---|
| K233813 | Bearing nsPVA Express™ | 2023 | 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?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K233813 (Merit Medical Systems, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NAJ devicesNAJ Agents, Embolic, For Treatment Of Uterine Fibroids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NAJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NAJ
Too few NAJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NAJ
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAJ
3in 2025
MAUDE reports naming product code NAJ, 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 | 46 |
| 2008 | 1 | — | 0 | 23 |
| 2009 | 0 | — | 1 | 11 |
| 2010 | 1 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 21 |
| 2013 | 1 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Bearing™ nsPVA Embolization Particles are used for the embolization of peripheral
hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous
malformations (AVMs).
Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.
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/K130259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130259: Bearing Nspva Embolization Particles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130259
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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